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Comparison of Hallux Interphalangeal Joint Arthrodesis Fixation Techniques: A Retrospective Multicenter Study
The Journal of Foot & Ankle Surgery xxx (2015) 1–6
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Original Research
Comparison of Hallux Interphalangeal Joint Arthrodesis Fixation Techniques: A Retrospective Multicenter Study Jakob C. Thorud, DPM, MS, AACFAS 1, Tyler Jolley, DPM, MHA 2, Naohiro Shibuya, DPM, MS, FACFAS 3, Eric Lew, DPM, AACFAS 4, Matthew Britt, DPM 5, Ted Butterfield, DPM 6, Alan Boike, DPM, FACFAS 7, Mark Hardy, DPM, FACFAS 8, Steve Brancheau, DPM, FACFAS 9, Travis Motley, DPM, MS, FACFAS 10, Daniel C. Jupiter, PhD 11 1
Staff, Central Texas Veterans Affairs Health Care System; and Staff, Baylor Scott and White Health, Temple, TX Third Year Resident, Baylor Scott and White Health, Central Texas Veterans Affairs Health Care System, Texas A&M Health Science Center, Temple, TX 3 Associate Professor, Department of Surgery, Texas A&M Health Science Center College of Medicine; Chief, Section of Podiatry, Central Texas Veterans Affairs Health Care System; and Staff, Baylor Scott and White Health, Temple, TX 4 Fellow, University of Arizona College of Medicine, Southern Arizona Limb Salvage Alliance, Tuscan, AZ 5 Physician, Private Practice, Mesquite, TX 6 Third-Year Resident, University of North Texas Health Science Center/John Peter Smith Hospital, Fort Worth, TX 7 Dean, Kent State University College of Podiatric Medicine, Independence, OH 8 Chief, Foot and Ankle Services, Mercy Health Foot and Ankle/HealthSpan Physicians, Cleveland Heights, OH 9 Director, Hunt Regional Healthcare Podiatry Residency Program, Hunt Regional Healthcare, Greenville, TX 10 Associate Professor, University of North Texas Health Science Center/John Peter Smith Hospital, Fort Worth, TX 11 Assistant Professor, Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston, TX 2
a r t i c l e i n f o
a b s t r a c t
Level of Clinical Evidence: 3
Few studies have investigated the complications that occur after hallux interphalangeal joint arthrodesis. The present study evaluated complications in 152 patients aged 18 to 80 years from 2005 to 2012 from 4 different academic institutions after hallux interphalangeal joint arthrodesis. Overall, 65.8% of the patients had 1 complication. Infections occurred in 16.5%, dehiscence in 12.5%, and reoperations in 27.0%. The clinical nonunion rate was 17.8%, and the radiographic nonunion rate was 13.8%. After logistic regression analysis, only the study site and peripheral neuropathy were associated with having 1 complication (p < .01 and p < .05, respectively). Single screw fixation compared with other fixation did not have a statistically significant influence on the postoperative complications. However, when fixation was expanded to 4 categories, single screw fixation had lower infection and reoperation rates than either crossed Kirschner wires or other fixation category but not compared with crossed screws on multivariate logistic regression analysis. Although additional studies are warranted, the findings from the present study might aid in both the prognosis of complications and the support of the use of a single screw over crossed Kirchner wire fixation in hallux interphalangeal joint arthrodesis. Ó 2015 by the American College of Foot and Ankle Surgeons. All rights reserved.
Keywords: fusion great toe intramedullary screw
Hallux interphalangeal joint (HIPJ) arthrodesis procedures have been used for many different pathologic entities, including neuromuscular disorders, arthritic conditions, congenital deformities, and iatrogenic conditions (1). However, very few studies have been conducted to guide surgeons regarding the best method of fixation. In 1943, O’Donoghue and Stauffer (2) described Kirschner wire
Financial Disclosure: None reported. Conflict of Interest: None reported. Address correspondence to: Jakob C. Thorud, DPM, MS, AACFAS, Central Texas Veterans Affairs Health Care System, 1901 Veterans Memorial Drive, Temple, TX 76504. E-mail address: [email protected] (J.C. Thorud).
fixation for the stabilization of the HIPJ arthrodesis site; however, others have reported high rates of pseudoarthrosis (44%) using this technique (3). A single intramedullary screw technique was introduced to improve this failure rate (3,4). Other modifications of Kirschner wire and screw fixation have also been described, including V-osteotomy with an obliquely placed screw, a bucket handle technique, and a combination of a single screw and Kirschner wire (1,2,5). External fixation has also been described as a method for HIPJ arthrodesis (6). Other methods include tenodesis of extensor halluces longus to the extensor digitorum brevis, stabilization with smooth and threaded Kirschner wires, and intramedullary screw fixation (7).
1067-2516/$ - see front matter Ó 2015 by the American College of Foot and Ankle Surgeons. All rights reserved. http://dx.doi.org/10.1053/j.jfas.2015.04.007
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J.C. Thorud et al. / The Journal of Foot & Ankle Surgery xxx (2015) 1–6
To the best of our knowledge, no reports of nonunion rates with the use of crossed screws for HIPJ arthrodesis have been published. Furthermore, only 1 study has reported the results from crossed Kirschner wires, and no study has compared the 2 most common techniques, single intramedullary screw and crossed Kirschner wire fixation (Fig. 1). The present study compared the postoperative complications occurring with different fixation techniques for HIPJ arthrodesis. A retrospective evaluation of patients who had undergone hallux interphalangeal joint arthrodesis at 4 academic institutions from January 1, 2005 to August 1, 2012 was performed. The present study specifically investigated the complications of infection, dehiscence, deep venous thrombus (DVT) or pulmonary embolism (PE), reoperation, clinical union, radiographic union, and any complications. The most popular fixation techniques of a single intramedullary screw, crossed Kirschner wire, and crossed screws were of clinical interest, and all other fixation techniques were combined into 1 group. Owing to the small sample sizes, for analysis we combined the crossed screws, crossed wires, and others into 1 group and compared these with the single screw technique. Patients and Methods This was a retrospective study. Patients who had undergone HIPJ arthrodesis at 4 institutions (Scott and White Healthcare, John Peter Smith Hospital, Cleveland Clinic, and Hunt Regional Healthcare) from January 1, 2005 to August 1, 2012 were included. The patients were identified using the Common Procedural Terminology code (code 28755) for HIPJ arthrodesis. Patients were included for the medical record review if they had undergone an HIPJ arthrodesis procedure and were 18 to 80 years old. The patients were excluded if the procedure had been revision arthrodesis. Only 1 side was included for patients who had undergone bilateral procedures. The side was chosen by random selection. The smoking history was defined as follows. The patient was considered an active smoker if documentation was present of smoking within the 2 weeks before surgery or the patient had returned to smoking in the postoperative period. Patients who had quit smoking >2 weeks before surgery and had not restarted during the postoperative period were categorized as having quit smoking. Infection was defined as the documented suspicion of infection and prescription of an antibiotic within the postoperative period as determined by the treating physician. Wound dehiscence was defined as documented delay of healing by the treating physician, the need for adjunctive wound healing measures, or the failure of sutures to maintain well-approximated skin
margins. DVT or PE was recorded if the patient was diagnosed within 3 months after the procedure. Clinical union was defined as the absence of motion or pain with attempted range of motion of the HIPJ with 6 weeks of follow-up. The patient was considered to have clinical nonunion if the criteria for clinical union had not been met at the last follow-up examination and that follow-up examination occurred >6 weeks postoperatively, or if the patient had a undergone reoperation <6 weeks after surgery. Radiographic union was defined as follows for the purposes of the present study: the presence of 2 cortical continuations or bridging at the arthrodesis site, absence of hardware failure, and the absence of lytic gapping of the arthrodesis site. Delayed union was defined as failure to meet criteria for union at 3 to 6 months. Nonunion was defined as failure to meet the criteria for union after 6 months. If the patient had <3 months of radiographic data, their union or nonunion status was not considered unless evidence of union was present with 6 weeks of radiographic evidence (Fig. 2). Primary Outcome The primary outcome was the presence of 1 complication (i.e., infection, dehiscence, DVT/PE, reoperation, clinical nonunion, radiographic delayed union or nonunion). The fixation technique was dichotomized to either a single intramedullary screw or other fixation types to be able to perform a meaningful statistical analysis. Univariate logistic regression analysis was performed for the following variables: site, body mass index (BMI) group (underweight, <18.5 kg/m2; normal, 18.5 to 24.9 kg/m2; overweight, 25 to 29.9 kg/m2, and obese, 30 kg/m2), gender, smoking history (active, quit, or never), number of operative diagnoses, primary diagnosis for operation (hallux malleus, ulcer, degenerative joint disease, and others), fixation type (single screw versus others), side, 1 comorbidity, and also by each comorbidity (Charcot-Marie-Tooth, degenerative joint disease, cerebral vascular accident, diabetes mellitus [DM], peripheral neuropathy [PN], rheumatoid disease, neurologic disease). Exact chi-square tests were used to compare categorical variables. Kruskal-Wallis tests were used to compare 1 nominal and 1 ordinal variable, specifically for age. Variables significant at a 0.25 significance level on univariate regression analysis were included in the variable selection procedure. Because the focus of the present study was to determine the incidence of any complications with the different fixation techniques (single screw versus others), the variable fixation type was included in the final model, although it was not selected in the variable selection process. Forward, backward, and stepwise selection methods were used. The fit of the model was assessed using the Hosmer-Lemeshow test, and regression diagnostics were run to investigate the presence of influential observations. An a level of 0.05 was considered statistically significant for all final analyses. The profile likelihood was used to compute the 95% confidence intervals (CIs) of the odds ratios (ORs). The analysis was performed using SAS 9.2. R (SAS Institute, Cary, NC). Secondary Outcomes The secondary outcomes were individual complications (i.e., infection, dehiscence, DVT/PE, reoperation, clinical nonunion, radiographic delayed union or nonunion).
Fig. 1. Fixation methods. Fixation methods used for arthrodesis of the hallux interphalangeal joint. (A) Crossed Kirschner wires. (B) Crossed screws. (C) Single intramedullary screw.
J.C. Thorud et al. / The Journal of Foot & Ankle Surgery xxx (2015) 1–6
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Fig. 2. Assessment of nonunions. Radiographic union was defined as the presence of 2 cortical continuations or bridging at the arthrodesis site, the absence of hardware failure, and the absence of lytic gapping of the arthrodesis site. (A) Categorized as nonunion, demonstrating the absence of cortical continuations (parallel lines), hardware failure (arrow), and lytic gapping at the arthrodesis site (bracket). (B) Categorized as union, demonstrating 2 cortical continuations (parallel lines), the absence of hardware failure, and no lytic gapping at the arthrodesis site.
Fixation was categorized into single screw, crossed screws, and other. Exact chi-square tests were used to compare the nominal variables. Univariate analyses on the variables of interest were performed, and variables with p .25 were included in the final model selection. Variable selection was performed using stepwise, backward, and forward procedures. Partial likelihood methods were used to calculate the 95% CIs for the ORs. Hosmer-Lemeshow and C-statistics were used to assess the goodness-of-fit of the models. Residual diagnostics were performed with the predicted probabilities and deviance residuals. Analysis was performed using SAS 9.2. R (SAS Institute).
Results A total of 161 HIPJ arthrodesis procedures were identified. Nine patients had undergone bilateral procedures, leaving a total of 152 subjects with 105 females and 47 males. The demographic data are listed in Table 1. The frequencies of the postoperative complications are listed in Table 2. The primary indications for the procedure were as follows: hallux malleus in 69, ulcer in 16, degenerative joint disease in 50, and other in 17. Additional procedures at HIPJ arthrodesis were performed as follows: lesser hammertoe repair in 63, first ray procedures in 19, lesser ray procedures in 9, and Jones tenosuspension in 2. Reoperation was required in 41 patients (hardware removal in 27, amputation in 5, revision of HIPJ fusion in 8, and other in 3). Agreement between clinical and radiographic union was not overly strong (Table 3). Cohen’s k showed a moderate agreement between diagnoses, with 66% agreement; however, 43% of that was due to chance. Primary Outcome The variables included in the model were study site, smoking history, side, PN, diabetes, and rheumatologic disease. Site and PN
were identified as predictors of complications. The final model included study site, PN, and fixation technique. Site 1 had complications in 33 of 64 patients, site 2 had 55 complications in 69 patients, site 3 had 9 complications in 10 patients, and site 4 had 3 complications in 9 patients. After logistic regression analysis, site and PN remained significant (p < .01 and p < .05, respectively). The fixation technique was not associated with the primary outcome (p ¼ .41; Table 4). The deviance goodness-of-fit test and Hosmer-Lemeshow test indicated a good model fit to the data. Regression diagnostics did not show any outliers or influential observations, and the c-statistics indicated a good prediction level (c ¼ 0.72). Secondary Outcomes The complications stratified by fixation technique are listed in Table 5. The exact chi-square test indicated an association between fixation and infection (p < .01) and fixation and reoperation (p < .01). However, no association was found between fixation and dehiscence (p ¼ .10), fixation and clinical union (p ¼ .23), fixation and radiographic union (p ¼ .15), and fixation and any complication (p ¼ .33). Univariate analyses indicated that age, diabetes, fixation, and PN were associated with fixation and reoperation. Multivariate logistic regression analysis was performed for infection and reoperation: fixation technique and PN, and fixation and DM, respectively, were included in the models. Fixation technique and PN were significantly associated with the occurrence of infection (p < .01 and p < .01, respectively). Fixation technique and DM were significantly associated with reoperation (p < .01 and p < .01, respectively; Table 6).
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Table 1 Demographic data (N ¼ 152)*
Table 3 Radiographic versus clinical union
Variable
Value
Age (y) BMI (kg/m2) Gender Male Female Tobacco or smoking history Active smoker Quit (>2 wk) Never smoked Fixation Crossed Kirschner wires Crossed screws Single screw Other Side Right Left Comorbidities DM PN DJD CMT CVA Rheumatologic Ulcer
55.7 14.5 29.2 7.1 47 (30.9) 105 (69.1) 25 (17.8) 46 (30.9) 78 (52.4) 21 17 98 11
(13.8) (11.2) (64.5) (6.2)
83 (54.6) 69 (45.4) 40 48 24 4 8 22 23
(26.3) (31.6) (36.4) (2.6) (5.3) (14.5) (15.1)
Abbreviations: BMI, body mass index; CMT, Charcot-Marie-Tooth (disease); CVA, cerebral vascular accident; DJD, degenerative joint disease; DM, diabetes mellitus; PN, peripheral neuropathy. Data presented as mean standard deviation or n (%). * Total of 152 patients with 152 arthrodesis procedures (only one side was selected by random selection in patients with bilateral procedures).
To analyze the relationships between comorbidities and complications, multiple factors were considered. The following comorbidities were evaluated: BMI, smoking history, rheumatoid arthritis, age, gender, PN, cerebrovascular accident, DM, and Charcot-Marie-Tooth disease. Individual comorbidities were assessed for an association with each of the following complications: infection, dehiscence, reoperation, clinical nonunion, and radiographic nonunion. PN and DM were the only comorbidities that were statistically significantly related to the occurrence of infection. In terms of PN, 15 Table 2 Postoperative complications (N ¼ 152)* Complication
n (%)
Infection Dehiscence DVT/PE Reoperation Amputation HWR Revision Other Clinical union Union Nonunion <6 wk or insufficient data Radiographic Union Delayed union Nonunion Radiographic follow-up <3 mo Reoperation (failed outcome) Reoperation (union after HWR) Lost to follow-up
25 19 4 41 5/41 27/41 8/41 3/41
(16.5) (12.5) (2.6) (27) (11.6) (62.8) (18.6) (7)
104 (68.4) 27 (17.8) 21 (13.8) 81 9 21 41 11 3 27
(53.8) (5.9) (13.8) (27) (7.2) (2) (17.8)
Abbreviations: DVT, deep venous thrombosis; HWR, hardware removal; PE, pulmonary embolism. * Total of 152 patients with 152 arthrodesis procedures (only 1 side was selected by random selection in patients with bilateral procedures).
Radiographic delayed/NU Radiographic union Total
Clinical Delayed/NU (n)
Clinical Union (n)
Total (n)
17 2 19
10 74 84
27 76 103
Abbreviation: NU, nonunion. Excluded 49 subjects without enough data.
of 33 patients (45.5%) with PN had an infection and 10 of 119 patients (8.4%) without PN had an infection (p < .01). In terms of DM, 14 of 40 patients (35%) with DM developed an infection and 11 of 101 patients (10.9%) without DM developed an infection (p < .01). Regarding dehiscence, PN and DM were the only comorbidities that were statistically significantly related to the occurrence of dehiscence. In terms of PN, 9 of 33 patients (27.3%) with PN developed dehiscence and 10 of 119 patients (8.4%) without PN developed dehiscence (p < .01). In terms of DM, 10 of 40 patients (25%) with DM experienced dehiscence and 9 of 112 patients (8.0%) without DM experienced dehiscence (p < .01). Regarding reoperation, DM was the only comorbidity that was statistically significantly related to the occurrence of reoperation. In terms of DM and reoperation, 17 of 40 patients (42.5%) with DM required a reoperation and 24 of 112 patients (21.4%) without DM required reoperation (p < .01). Regarding clinical nonunion, BMI, PN, and DM were the only comorbidities that were statistically significantly related to the occurrence of a clinical nonunion. For BMI, the patients were divided into 4 categories according to the BMI value: underweight (<18.5 kg/ m2), normal (18.5 to 24.9 kg/m2), overweight (25 to 29.9 kg/m2), and obese (>30 kg/m2). The clinical nonunion rates were as follows: underweight, 2 of 8 (25%); normal, 2 of 36 (5.6%); overweight, 6 of 38 (15.8%); and obese, 17 of 49 (34.7%; p < .01). In terms of PN and clinical nonunion, 11 of 27 patients (41%) with PN experienced clinical nonunion and 16 of 104 (15.4%) without PN had clinical nonunion (p < .01). In terms of DM and clinical nonunion, 14 of 44 patients (31.8%) with DM had clinical nonunion and 13 of 97 (13.4%) without DM had clinical nonunion (p < .01). Regarding radiographic nonunion, PN was the only comorbidity that was statistically significantly related to the occurrence of radiographic nonunion. In terms of PN and radiographic nonunion, 11 of 23 patients (47.8%) with PN had radiographic nonunion and 19 of 88 patients (21.6%) without PN had radiographic nonunion (p < .01). Discussion Our study found a high rate of complications after HIPJ arthrodesis in our studied institutions. Infections occurred in 16.5%, dehiscence in 12.5%, and reoperations in 27%, although most of reoperations were
Table 4 Likelihood confidence interval for odds ratios (N ¼ 152)* Effect
Estimate
95% Confidence Interval
Site 2 versus site 1 Site 3 versus site 1 Site 4 versus site 1 Peripheral neuropathy Fixation technique: other versus single screw
4.870 8.875 0.584 2.670 1.382
2.196 1.484 0.113 1.048 0.643
to to to to to
11.343 170.769 2.501 7.399 3.047
After multivariate analysis, only the institutional site and the presence of peripheral neuropathy remained significant for any complication. * Total of 152 patients with 152 arthrodesis procedures (only one side was selected by random selection in patients with bilateral procedures).
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Table 5 Complications by fixation technique (N ¼ 152)* Fixation Type
Infection
Dehiscence
Reoperation
Clinical NU
Radiographic NU
Any Complication
Crossed Kirschner wires Crossed screws Single screw Other Total
7/21 4/17 8/98 6/16 25/152
1/21 3/17 10/98 5/16 19/152
11/21 6/17 15/98 9/16 41/152
6/14 3/16 14/87 4/14 27/131
6/10 3/13 17/74 4/14 30/111
15/21 13/17 72/98 16/16 116/152
(33.3) (23.5) (8.2) (37.5) (16.5)
(4.8) (17.7) (10.2) (31.3) (12.5)
(52.4) (35.3) (15.3) (56.3) (27.0)
(42.9) (18.8) (16.1) (28.6) (20.6)
(60.0) (23.1) (23.0) (28.6) (27.0)
(71.4) (76.5) (64.5) (100.0) (76.3)
Abbreviation: NU, nonunion. Data presented as n (%). Number of complications by each fixation technique for subjects with available data. Exact chi-square test indicated an association between fixation and infection (p < .01), fixation and reoperation (p < .01), but no association was found between fixation and dehiscence (p ¼ .10), fixation and clinical union (p ¼ .23), fixation and radiographic union (p ¼ .15), and any complication (p ¼ .33). * Total of 152 patients with 152 arthrodesis procedures (only 1 side was selected by random selection in patients with bilateral procedures).
for hardware removal (Fig. 3). Furthermore, clinical nonunion was confirmed in 17.8% and radiographic nonunion in 13.8%. Others have reported nonunion rates of 0% to 44% (3,4,7,8). Infections and dehiscence have been reported in the range of 0% to 15% for HIPJ arthrodesis (3,9,10). However, many studies regarding HIPJ arthrodesis tend to focus on nonunion rates and to not report the infection rates (5,7,8). The reoperation rates have been reported at 16% to 40% (7,11). The high complication rates of our study might have resulted from patient selection. Our population included DM in 26.3% of patients, PN in 31.6%, and ulcerations in 15.1%. Other studies have reported results in patients with pes cavus, hereditary sensory motor neuropathy, spina bifida, cerebral palsy, poliomyelitis, traumatic arthritis, osteoarthritis, systemic arthritides, and hallux abductus interphalangeus deformities. However, very few have evaluated the outcomes of HIPJ arthrodesis in patients with DM (5,7,11). The oversampling of patients with DM in the present study could have increased the complication rates because poorly controlled and complicated DM have been shown to be significant risk factors for postoperative complications (12–14). In our primary analysis, the fixation technique, when dichotomized into single screw and other fixation, was not associated with having 1 complication in our study. In our secondary outcomes, in which fixation was categorized into 4 groups (crossed screws, single screw, crossed Kirchner wires, and other), and the outcome
was specific to each complication, fixation was associated with infection and reoperation on multivariate analysis. However, the stability of the analysis could be in question, as evidenced by the large 95% CI. Although our primary analysis was performed to achieve statistically meaningful results, this might have masked some differences. Previous studies of the adjacent joint, the first metatarsophalangeal joint, have also reported no difference with the fixation technique (15). Furthermore, the complication rates differed by institution. Also, the preoperative comorbidities were significantly different among the 4 sites and this site difference remained after logistic regression analysis. However, the fixation technique did not differ among the sites. This might imply that the complications were largely dependent on the preoperative medical status, such as the presence of PN, and less on the fixation technique. Conceivably, all surgeons believed they used adequate fixation for the procedure at surgery and, thus, bone healing was affected by patient health and patient selection. However, when fixation was expanded to 4 categories, the single screw technique resulted in lower infection and reoperation rates than either crossed Kirschner wires or other fixation techniques but not crossed screws (Table 6). This does seem to support the use of single screw fixation rather than crossed Kirschner wires. In the present study, PN was associated with increased complications (OR 2.7, 95% CI 1.1 to 7.4) and infection (OR 10.6, 95% CI 3.8 to
Table 6 Odds ratio estimates for infection and reoperation (N ¼ 152)* Odds Ratio Infection Crossed Kirschner wires versus single screw Crossed Kirschner wires versus other Crossed Kirschner wires versus crossed screws Other versus single screw Crossed screws versus single screw Other versus crossed screws PN Reoperation Crossed Kirschner wires versus single screw Crossed Kirschner wires versus other Crossed Kirschner wires versus crossed screws Other versus single screw Crossed screws versus single screw Other versus crossed screws DM
Estimate 95% Confidence Intervals 5.41 0.61 1.13 8.90 4.79 1.86 10.61
(1.44 (0.12 (0.22 (2.12 (1.00 (0.34 (3.82
to to to to to to to
20.82) 2.96) 6.22) 38.83) 21.72) 10.90) 32.44)
6.16 0.77 1.88 7.97 3.28 2.43 3.03
(2.17 (0.20 (0.49 (2.51 (0.97 (0.59 (1.30
to to to to to to to
18.10) 2.98) 7.59) 26.80) 10.50) 10.80) 7.20)
Abbreviations: DM, diabetes mellitus; PN, peripheral neuropathy. On secondary outcome analysis comparing expanded fixation techniques (single screw, crossed Kirschner wire, crossed screws, and other), multivariate analysis identified fixation technique and PN as significant predictors of infection (p < .01 and p < .01, respectively). The fixation technique and DM were significant predictors of reoperation (p < .01 and p < .01 respectively). * Total of 152 patients with 152 arthrodesis procedures (only 1 side was selected by random selection in patients with bilateral procedures).
Fig. 3. Neuropathic patient with prominent screw visible through the open wound on the distal aspect of the hallux. The single screw was removed uneventfully. However, hardware removal was identified as the most common reason for reoperation, occurring in 17.8% of patients.
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32.4). Others have also found PN to be associated with complications in the foot and ankle, specifically bone healing complications. In a study that evaluated bone healing complications in patients with DM, 26 of 59 patients with PN (44%) had 1 bone healing complications (16). PN was the single most significant factor that affected bone healing compared with other factors such as glycosylated hemoglobin, peripheral vascular disease, tobacco use, history of ulceration, surgical time, and BMI (16). HIPJ arthrodesis has been used for treatment or as a prophylactic measure for ulcerations once nonoperative therapies have failed (17). In contrast, others have considered open ulcerations to be a contraindication for HIPJ fusion (5). Others have suggested Keller arthroplasty (18) or HIPJ arthroplasty (19) for hallux interphalangeal joint ulcerations. Given the high complications with HIPJ arthrodesis in the presence of PN, arthroplasty might be a reasonable alternative for these patients because it does not demand fusion of bone. The present study did not investigate the occurrence of re-ulceration in patients with ulcerations nor did our study allow for a direct comparison. Many studies have used vague definitions of nonunion. Therefore, the incidence of nonunion might not be easily comparable across studies. In a survey of 444 surgeons, nonunion definitions ranged from the absence of union at 2 to 12 months, and fewer than one half of the respondents used all the following criteria: cortical continuations, callus size, progressive loss of fracture line, ability to bear weight, and pain with palpation of fracture site (20). Our study used very specific criteria for delayed union and nonunion. This allowed for clear interpretation of the delayed union and nonunion definitions. Furthermore, our study also used separate clinical and radiographic nonunion definitions. Clinical and radiographic union is not interchangeable, which can be seen in Table 3. Of the 76 patients with radiographic evidence of union, 2 had clinical nonunion, and 10 of the 27 patients with radiographic nonunion had clinical union. Several limitations of the present study could have contributed to the results. First, owing to the retrospective nature of our study, we know that the fixation choice by each surgeon was not independent of other factors. Naturally, higher risk patients might have had more stable constructs. Some covariates were adjusted for in the regression analysis, but many other factors can play a role in the surgeon’s decision-making. The multicenter design, including many different surgeons, however, reduced any single surgeon’s impact in the present study. Second, our sample size might not have been large enough to build a stable model to compare the different fixation techniques. Thus, our primary outcome combined the fixation type into single screw versus others and only studied presence of any complications. Fixation was not found to be significantly associated with having 1 complication, but it was significantly associated with both reoperation and infection when the fixation groups were further categorized into 4 groups. The validity of this finding is, however, in question, because the 95% CIs were large. Third, our study contained a large number of patients with insufficient data to determine whether radiographic union was present. Although clinical union was included to capture patients with >6 weeks of follow-up, 27% of patients either did not have a long enough follow-up period or the documentation was insufficient to determine whether union had occurred. Despite the limitations, the present study had the largest population thus far used to investigate HIPJ fusion procedures (the second
largest was Shives and Johnson [3] in 1980, with 139 patients). The present study has demonstrated the high postoperative complication rates seen with HIPJ arthrodesis. The fixation technique was not associated with overall complication rate. However, PN and study site were associated with the incidence of postoperative complications. When treated individually and separately, PN and fixation type were associated with infection and DM and fixation type were associated with reoperation. These data seem to support the use of single screw fixation, but this result must be taken with caution and larger randomized trials are warranted to validate our findings. Acknowledgments We thank Yolanda Munoz Maldonado, PhD, biostatistician, Baylor Scott and White, Temple, TX. References 1. Moyer J, Lowery C, Knox J. Hallux IPJ fusion. Clin Podiatr Med Surg 21:51–64, 2004. 2. O’Donoghue D, Stauffer R. An improved operative method for obtaining bony fusion of the great toe. Surg Gynecol Obstet 76:498–500, 1943. 3. Shives TC, Johnson KA. Arthrodesis of the interphalangeal joint of the great toedan improved technique. Foot Ankle 1:26–29, 1980. 4. Langford JH, Fenton CF III. Hallux interphalangeal arthrodesis. J Am Podiatry Assoc 72:155–157, 1982. 5. Derner R, Meyr AJ. Hallux interphalangeal joint arthrodesis. J Foot Ankle Surg 48:408–410, 2009. 6. Sharon SM, McClain J. An alternative fixation technique when performing hallux interphalangeal joint fusions. J Foot Surg 24:132–135, 1985. 7. Asirvatham R, Rooney RJ, Watts HG. Stabilization of the interphalangeal joint of the big toe: comparison of three methods. Foot Ankle 13:181–187, 1992. 8. Faraj AA. Modified Jones procedure for post-polio claw hallux deformity. J Foot Ankle Surg 36:356–359, 1997. 9. Brutus JP, Palmer AK, Mosher JF, Harley BJ, Loftus JB. Use of a headless compressive screw for distal interphalangeal joint arthrodesis in digits: clinical outcome and review of complications. J Hand Surg Am 31:85–89, 2006. 10. Kimmel HM, Garrow S. A comparison of end-to-end versus “V” arthrodesis procedures for the correction of digital deformities. Clin Podiatr Med Surg 13:239– 250, 1996. 11. Dhukaram V, Roche A, Walsh H. Interphalangeal joint fusion of the great toe. Foot Ankle Surg 9:161–163, 2003. 12. Myers TG, Lowery NJ, Frykberg RG, Wukich DK. Ankle and hindfoot fusions: comparison of outcomes in patients with and without diabetes. Foot Ankle Int 33:20–28, 2012. 13. Perlman MH, Thordarson DB. Ankle fusion in a high risk population: an assessment of nonunion risk factors. Foot Ankle Int 20:491–496, 1999. 14. Younger AS, Awwad MA, Kalla TP, de Vries G. Risk factors for failure of transmetatarsal amputation in diabetic patients: a cohort study. Foot Ankle Int 30:1177–1182, 2009. 15. Hyer CF, Scott RT, Swiatek M. A retrospective comparison of four plate constructs for first metatarsophalangeal joint fusion: static plate, static plate with lag screw, locked plate, and locked plate with lag screw. J Foot Ankle Surg 51:285–287, 2012. 16. Shibuya N, Humphers JM, Fluhman BL, Jupiter DC. Factors associated with nonunion, delayed union, and malunion in foot and ankle surgery in diabetic patients. J Foot Ankle Surg 52:207–211, 2013. 17. Wukich DK. Current concepts review: diabetic foot ulcers. Foot Ankle Int 31:460– 467, 2010. 18. Armstrong DG, Lavery LA, Vazquez JR, Short B, Kimbriel HR, Nixon BP, Boulton AJ. Clinical efficacy of the first metatarsophalangeal joint arthroplasty as a curative procedure for hallux interphalangeal joint wounds in patients with diabetes. Diabetes Care 26:3284–3287, 2003. 19. Lew E, Nicolosi N, McKee P. Evaluation of hallux interphalangeal joint arthroplasty compared with nonoperative treatment of recalcitrant hallux ulceration. J Foot Ankle Surg, 2014 Nov 13. http://dx.doi.org/10.1053/j.jfas.2014.08.014 [Epub ahead of print]. 20. Bhandari M, Guyatt GH, Swiontkowski MF, Tornetta P III, Sprague S, Schemitsch EH. A lack of consensus in the assessment of fracture healing among orthopaedic surgeons. J Orthop Trauma 16:562–566, 2002.
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Original Research
Comparison of Hallux Interphalangeal Joint Arthrodesis Fixation Techniques: A Retrospective Multicenter Study Jakob C. Thorud, DPM, MS, AACFAS 1, Tyler Jolley, DPM, MHA 2, Naohiro Shibuya, DPM, MS, FACFAS 3, Eric Lew, DPM, AACFAS 4, Matthew Britt, DPM 5, Ted Butterfield, DPM 6, Alan Boike, DPM, FACFAS 7, Mark Hardy, DPM, FACFAS 8, Steve Brancheau, DPM, FACFAS 9, Travis Motley, DPM, MS, FACFAS 10, Daniel C. Jupiter, PhD 11 1
Staff, Central Texas Veterans Affairs Health Care System; and Staff, Baylor Scott and White Health, Temple, TX Third Year Resident, Baylor Scott and White Health, Central Texas Veterans Affairs Health Care System, Texas A&M Health Science Center, Temple, TX 3 Associate Professor, Department of Surgery, Texas A&M Health Science Center College of Medicine; Chief, Section of Podiatry, Central Texas Veterans Affairs Health Care System; and Staff, Baylor Scott and White Health, Temple, TX 4 Fellow, University of Arizona College of Medicine, Southern Arizona Limb Salvage Alliance, Tuscan, AZ 5 Physician, Private Practice, Mesquite, TX 6 Third-Year Resident, University of North Texas Health Science Center/John Peter Smith Hospital, Fort Worth, TX 7 Dean, Kent State University College of Podiatric Medicine, Independence, OH 8 Chief, Foot and Ankle Services, Mercy Health Foot and Ankle/HealthSpan Physicians, Cleveland Heights, OH 9 Director, Hunt Regional Healthcare Podiatry Residency Program, Hunt Regional Healthcare, Greenville, TX 10 Associate Professor, University of North Texas Health Science Center/John Peter Smith Hospital, Fort Worth, TX 11 Assistant Professor, Department of Preventive Medicine and Community Health, University of Texas Medical Branch, Galveston, TX 2
a r t i c l e i n f o
a b s t r a c t
Level of Clinical Evidence: 3
Few studies have investigated the complications that occur after hallux interphalangeal joint arthrodesis. The present study evaluated complications in 152 patients aged 18 to 80 years from 2005 to 2012 from 4 different academic institutions after hallux interphalangeal joint arthrodesis. Overall, 65.8% of the patients had 1 complication. Infections occurred in 16.5%, dehiscence in 12.5%, and reoperations in 27.0%. The clinical nonunion rate was 17.8%, and the radiographic nonunion rate was 13.8%. After logistic regression analysis, only the study site and peripheral neuropathy were associated with having 1 complication (p < .01 and p < .05, respectively). Single screw fixation compared with other fixation did not have a statistically significant influence on the postoperative complications. However, when fixation was expanded to 4 categories, single screw fixation had lower infection and reoperation rates than either crossed Kirschner wires or other fixation category but not compared with crossed screws on multivariate logistic regression analysis. Although additional studies are warranted, the findings from the present study might aid in both the prognosis of complications and the support of the use of a single screw over crossed Kirchner wire fixation in hallux interphalangeal joint arthrodesis. Ó 2015 by the American College of Foot and Ankle Surgeons. All rights reserved.
Keywords: fusion great toe intramedullary screw
Hallux interphalangeal joint (HIPJ) arthrodesis procedures have been used for many different pathologic entities, including neuromuscular disorders, arthritic conditions, congenital deformities, and iatrogenic conditions (1). However, very few studies have been conducted to guide surgeons regarding the best method of fixation. In 1943, O’Donoghue and Stauffer (2) described Kirschner wire
Financial Disclosure: None reported. Conflict of Interest: None reported. Address correspondence to: Jakob C. Thorud, DPM, MS, AACFAS, Central Texas Veterans Affairs Health Care System, 1901 Veterans Memorial Drive, Temple, TX 76504. E-mail address: [email protected] (J.C. Thorud).
fixation for the stabilization of the HIPJ arthrodesis site; however, others have reported high rates of pseudoarthrosis (44%) using this technique (3). A single intramedullary screw technique was introduced to improve this failure rate (3,4). Other modifications of Kirschner wire and screw fixation have also been described, including V-osteotomy with an obliquely placed screw, a bucket handle technique, and a combination of a single screw and Kirschner wire (1,2,5). External fixation has also been described as a method for HIPJ arthrodesis (6). Other methods include tenodesis of extensor halluces longus to the extensor digitorum brevis, stabilization with smooth and threaded Kirschner wires, and intramedullary screw fixation (7).
1067-2516/$ - see front matter Ó 2015 by the American College of Foot and Ankle Surgeons. All rights reserved. http://dx.doi.org/10.1053/j.jfas.2015.04.007
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To the best of our knowledge, no reports of nonunion rates with the use of crossed screws for HIPJ arthrodesis have been published. Furthermore, only 1 study has reported the results from crossed Kirschner wires, and no study has compared the 2 most common techniques, single intramedullary screw and crossed Kirschner wire fixation (Fig. 1). The present study compared the postoperative complications occurring with different fixation techniques for HIPJ arthrodesis. A retrospective evaluation of patients who had undergone hallux interphalangeal joint arthrodesis at 4 academic institutions from January 1, 2005 to August 1, 2012 was performed. The present study specifically investigated the complications of infection, dehiscence, deep venous thrombus (DVT) or pulmonary embolism (PE), reoperation, clinical union, radiographic union, and any complications. The most popular fixation techniques of a single intramedullary screw, crossed Kirschner wire, and crossed screws were of clinical interest, and all other fixation techniques were combined into 1 group. Owing to the small sample sizes, for analysis we combined the crossed screws, crossed wires, and others into 1 group and compared these with the single screw technique. Patients and Methods This was a retrospective study. Patients who had undergone HIPJ arthrodesis at 4 institutions (Scott and White Healthcare, John Peter Smith Hospital, Cleveland Clinic, and Hunt Regional Healthcare) from January 1, 2005 to August 1, 2012 were included. The patients were identified using the Common Procedural Terminology code (code 28755) for HIPJ arthrodesis. Patients were included for the medical record review if they had undergone an HIPJ arthrodesis procedure and were 18 to 80 years old. The patients were excluded if the procedure had been revision arthrodesis. Only 1 side was included for patients who had undergone bilateral procedures. The side was chosen by random selection. The smoking history was defined as follows. The patient was considered an active smoker if documentation was present of smoking within the 2 weeks before surgery or the patient had returned to smoking in the postoperative period. Patients who had quit smoking >2 weeks before surgery and had not restarted during the postoperative period were categorized as having quit smoking. Infection was defined as the documented suspicion of infection and prescription of an antibiotic within the postoperative period as determined by the treating physician. Wound dehiscence was defined as documented delay of healing by the treating physician, the need for adjunctive wound healing measures, or the failure of sutures to maintain well-approximated skin
margins. DVT or PE was recorded if the patient was diagnosed within 3 months after the procedure. Clinical union was defined as the absence of motion or pain with attempted range of motion of the HIPJ with 6 weeks of follow-up. The patient was considered to have clinical nonunion if the criteria for clinical union had not been met at the last follow-up examination and that follow-up examination occurred >6 weeks postoperatively, or if the patient had a undergone reoperation <6 weeks after surgery. Radiographic union was defined as follows for the purposes of the present study: the presence of 2 cortical continuations or bridging at the arthrodesis site, absence of hardware failure, and the absence of lytic gapping of the arthrodesis site. Delayed union was defined as failure to meet criteria for union at 3 to 6 months. Nonunion was defined as failure to meet the criteria for union after 6 months. If the patient had <3 months of radiographic data, their union or nonunion status was not considered unless evidence of union was present with 6 weeks of radiographic evidence (Fig. 2). Primary Outcome The primary outcome was the presence of 1 complication (i.e., infection, dehiscence, DVT/PE, reoperation, clinical nonunion, radiographic delayed union or nonunion). The fixation technique was dichotomized to either a single intramedullary screw or other fixation types to be able to perform a meaningful statistical analysis. Univariate logistic regression analysis was performed for the following variables: site, body mass index (BMI) group (underweight, <18.5 kg/m2; normal, 18.5 to 24.9 kg/m2; overweight, 25 to 29.9 kg/m2, and obese, 30 kg/m2), gender, smoking history (active, quit, or never), number of operative diagnoses, primary diagnosis for operation (hallux malleus, ulcer, degenerative joint disease, and others), fixation type (single screw versus others), side, 1 comorbidity, and also by each comorbidity (Charcot-Marie-Tooth, degenerative joint disease, cerebral vascular accident, diabetes mellitus [DM], peripheral neuropathy [PN], rheumatoid disease, neurologic disease). Exact chi-square tests were used to compare categorical variables. Kruskal-Wallis tests were used to compare 1 nominal and 1 ordinal variable, specifically for age. Variables significant at a 0.25 significance level on univariate regression analysis were included in the variable selection procedure. Because the focus of the present study was to determine the incidence of any complications with the different fixation techniques (single screw versus others), the variable fixation type was included in the final model, although it was not selected in the variable selection process. Forward, backward, and stepwise selection methods were used. The fit of the model was assessed using the Hosmer-Lemeshow test, and regression diagnostics were run to investigate the presence of influential observations. An a level of 0.05 was considered statistically significant for all final analyses. The profile likelihood was used to compute the 95% confidence intervals (CIs) of the odds ratios (ORs). The analysis was performed using SAS 9.2. R (SAS Institute, Cary, NC). Secondary Outcomes The secondary outcomes were individual complications (i.e., infection, dehiscence, DVT/PE, reoperation, clinical nonunion, radiographic delayed union or nonunion).
Fig. 1. Fixation methods. Fixation methods used for arthrodesis of the hallux interphalangeal joint. (A) Crossed Kirschner wires. (B) Crossed screws. (C) Single intramedullary screw.
J.C. Thorud et al. / The Journal of Foot & Ankle Surgery xxx (2015) 1–6
3
Fig. 2. Assessment of nonunions. Radiographic union was defined as the presence of 2 cortical continuations or bridging at the arthrodesis site, the absence of hardware failure, and the absence of lytic gapping of the arthrodesis site. (A) Categorized as nonunion, demonstrating the absence of cortical continuations (parallel lines), hardware failure (arrow), and lytic gapping at the arthrodesis site (bracket). (B) Categorized as union, demonstrating 2 cortical continuations (parallel lines), the absence of hardware failure, and no lytic gapping at the arthrodesis site.
Fixation was categorized into single screw, crossed screws, and other. Exact chi-square tests were used to compare the nominal variables. Univariate analyses on the variables of interest were performed, and variables with p .25 were included in the final model selection. Variable selection was performed using stepwise, backward, and forward procedures. Partial likelihood methods were used to calculate the 95% CIs for the ORs. Hosmer-Lemeshow and C-statistics were used to assess the goodness-of-fit of the models. Residual diagnostics were performed with the predicted probabilities and deviance residuals. Analysis was performed using SAS 9.2. R (SAS Institute).
Results A total of 161 HIPJ arthrodesis procedures were identified. Nine patients had undergone bilateral procedures, leaving a total of 152 subjects with 105 females and 47 males. The demographic data are listed in Table 1. The frequencies of the postoperative complications are listed in Table 2. The primary indications for the procedure were as follows: hallux malleus in 69, ulcer in 16, degenerative joint disease in 50, and other in 17. Additional procedures at HIPJ arthrodesis were performed as follows: lesser hammertoe repair in 63, first ray procedures in 19, lesser ray procedures in 9, and Jones tenosuspension in 2. Reoperation was required in 41 patients (hardware removal in 27, amputation in 5, revision of HIPJ fusion in 8, and other in 3). Agreement between clinical and radiographic union was not overly strong (Table 3). Cohen’s k showed a moderate agreement between diagnoses, with 66% agreement; however, 43% of that was due to chance. Primary Outcome The variables included in the model were study site, smoking history, side, PN, diabetes, and rheumatologic disease. Site and PN
were identified as predictors of complications. The final model included study site, PN, and fixation technique. Site 1 had complications in 33 of 64 patients, site 2 had 55 complications in 69 patients, site 3 had 9 complications in 10 patients, and site 4 had 3 complications in 9 patients. After logistic regression analysis, site and PN remained significant (p < .01 and p < .05, respectively). The fixation technique was not associated with the primary outcome (p ¼ .41; Table 4). The deviance goodness-of-fit test and Hosmer-Lemeshow test indicated a good model fit to the data. Regression diagnostics did not show any outliers or influential observations, and the c-statistics indicated a good prediction level (c ¼ 0.72). Secondary Outcomes The complications stratified by fixation technique are listed in Table 5. The exact chi-square test indicated an association between fixation and infection (p < .01) and fixation and reoperation (p < .01). However, no association was found between fixation and dehiscence (p ¼ .10), fixation and clinical union (p ¼ .23), fixation and radiographic union (p ¼ .15), and fixation and any complication (p ¼ .33). Univariate analyses indicated that age, diabetes, fixation, and PN were associated with fixation and reoperation. Multivariate logistic regression analysis was performed for infection and reoperation: fixation technique and PN, and fixation and DM, respectively, were included in the models. Fixation technique and PN were significantly associated with the occurrence of infection (p < .01 and p < .01, respectively). Fixation technique and DM were significantly associated with reoperation (p < .01 and p < .01, respectively; Table 6).
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Table 1 Demographic data (N ¼ 152)*
Table 3 Radiographic versus clinical union
Variable
Value
Age (y) BMI (kg/m2) Gender Male Female Tobacco or smoking history Active smoker Quit (>2 wk) Never smoked Fixation Crossed Kirschner wires Crossed screws Single screw Other Side Right Left Comorbidities DM PN DJD CMT CVA Rheumatologic Ulcer
55.7 14.5 29.2 7.1 47 (30.9) 105 (69.1) 25 (17.8) 46 (30.9) 78 (52.4) 21 17 98 11
(13.8) (11.2) (64.5) (6.2)
83 (54.6) 69 (45.4) 40 48 24 4 8 22 23
(26.3) (31.6) (36.4) (2.6) (5.3) (14.5) (15.1)
Abbreviations: BMI, body mass index; CMT, Charcot-Marie-Tooth (disease); CVA, cerebral vascular accident; DJD, degenerative joint disease; DM, diabetes mellitus; PN, peripheral neuropathy. Data presented as mean standard deviation or n (%). * Total of 152 patients with 152 arthrodesis procedures (only one side was selected by random selection in patients with bilateral procedures).
To analyze the relationships between comorbidities and complications, multiple factors were considered. The following comorbidities were evaluated: BMI, smoking history, rheumatoid arthritis, age, gender, PN, cerebrovascular accident, DM, and Charcot-Marie-Tooth disease. Individual comorbidities were assessed for an association with each of the following complications: infection, dehiscence, reoperation, clinical nonunion, and radiographic nonunion. PN and DM were the only comorbidities that were statistically significantly related to the occurrence of infection. In terms of PN, 15 Table 2 Postoperative complications (N ¼ 152)* Complication
n (%)
Infection Dehiscence DVT/PE Reoperation Amputation HWR Revision Other Clinical union Union Nonunion <6 wk or insufficient data Radiographic Union Delayed union Nonunion Radiographic follow-up <3 mo Reoperation (failed outcome) Reoperation (union after HWR) Lost to follow-up
25 19 4 41 5/41 27/41 8/41 3/41
(16.5) (12.5) (2.6) (27) (11.6) (62.8) (18.6) (7)
104 (68.4) 27 (17.8) 21 (13.8) 81 9 21 41 11 3 27
(53.8) (5.9) (13.8) (27) (7.2) (2) (17.8)
Abbreviations: DVT, deep venous thrombosis; HWR, hardware removal; PE, pulmonary embolism. * Total of 152 patients with 152 arthrodesis procedures (only 1 side was selected by random selection in patients with bilateral procedures).
Radiographic delayed/NU Radiographic union Total
Clinical Delayed/NU (n)
Clinical Union (n)
Total (n)
17 2 19
10 74 84
27 76 103
Abbreviation: NU, nonunion. Excluded 49 subjects without enough data.
of 33 patients (45.5%) with PN had an infection and 10 of 119 patients (8.4%) without PN had an infection (p < .01). In terms of DM, 14 of 40 patients (35%) with DM developed an infection and 11 of 101 patients (10.9%) without DM developed an infection (p < .01). Regarding dehiscence, PN and DM were the only comorbidities that were statistically significantly related to the occurrence of dehiscence. In terms of PN, 9 of 33 patients (27.3%) with PN developed dehiscence and 10 of 119 patients (8.4%) without PN developed dehiscence (p < .01). In terms of DM, 10 of 40 patients (25%) with DM experienced dehiscence and 9 of 112 patients (8.0%) without DM experienced dehiscence (p < .01). Regarding reoperation, DM was the only comorbidity that was statistically significantly related to the occurrence of reoperation. In terms of DM and reoperation, 17 of 40 patients (42.5%) with DM required a reoperation and 24 of 112 patients (21.4%) without DM required reoperation (p < .01). Regarding clinical nonunion, BMI, PN, and DM were the only comorbidities that were statistically significantly related to the occurrence of a clinical nonunion. For BMI, the patients were divided into 4 categories according to the BMI value: underweight (<18.5 kg/ m2), normal (18.5 to 24.9 kg/m2), overweight (25 to 29.9 kg/m2), and obese (>30 kg/m2). The clinical nonunion rates were as follows: underweight, 2 of 8 (25%); normal, 2 of 36 (5.6%); overweight, 6 of 38 (15.8%); and obese, 17 of 49 (34.7%; p < .01). In terms of PN and clinical nonunion, 11 of 27 patients (41%) with PN experienced clinical nonunion and 16 of 104 (15.4%) without PN had clinical nonunion (p < .01). In terms of DM and clinical nonunion, 14 of 44 patients (31.8%) with DM had clinical nonunion and 13 of 97 (13.4%) without DM had clinical nonunion (p < .01). Regarding radiographic nonunion, PN was the only comorbidity that was statistically significantly related to the occurrence of radiographic nonunion. In terms of PN and radiographic nonunion, 11 of 23 patients (47.8%) with PN had radiographic nonunion and 19 of 88 patients (21.6%) without PN had radiographic nonunion (p < .01). Discussion Our study found a high rate of complications after HIPJ arthrodesis in our studied institutions. Infections occurred in 16.5%, dehiscence in 12.5%, and reoperations in 27%, although most of reoperations were
Table 4 Likelihood confidence interval for odds ratios (N ¼ 152)* Effect
Estimate
95% Confidence Interval
Site 2 versus site 1 Site 3 versus site 1 Site 4 versus site 1 Peripheral neuropathy Fixation technique: other versus single screw
4.870 8.875 0.584 2.670 1.382
2.196 1.484 0.113 1.048 0.643
to to to to to
11.343 170.769 2.501 7.399 3.047
After multivariate analysis, only the institutional site and the presence of peripheral neuropathy remained significant for any complication. * Total of 152 patients with 152 arthrodesis procedures (only one side was selected by random selection in patients with bilateral procedures).
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Table 5 Complications by fixation technique (N ¼ 152)* Fixation Type
Infection
Dehiscence
Reoperation
Clinical NU
Radiographic NU
Any Complication
Crossed Kirschner wires Crossed screws Single screw Other Total
7/21 4/17 8/98 6/16 25/152
1/21 3/17 10/98 5/16 19/152
11/21 6/17 15/98 9/16 41/152
6/14 3/16 14/87 4/14 27/131
6/10 3/13 17/74 4/14 30/111
15/21 13/17 72/98 16/16 116/152
(33.3) (23.5) (8.2) (37.5) (16.5)
(4.8) (17.7) (10.2) (31.3) (12.5)
(52.4) (35.3) (15.3) (56.3) (27.0)
(42.9) (18.8) (16.1) (28.6) (20.6)
(60.0) (23.1) (23.0) (28.6) (27.0)
(71.4) (76.5) (64.5) (100.0) (76.3)
Abbreviation: NU, nonunion. Data presented as n (%). Number of complications by each fixation technique for subjects with available data. Exact chi-square test indicated an association between fixation and infection (p < .01), fixation and reoperation (p < .01), but no association was found between fixation and dehiscence (p ¼ .10), fixation and clinical union (p ¼ .23), fixation and radiographic union (p ¼ .15), and any complication (p ¼ .33). * Total of 152 patients with 152 arthrodesis procedures (only 1 side was selected by random selection in patients with bilateral procedures).
for hardware removal (Fig. 3). Furthermore, clinical nonunion was confirmed in 17.8% and radiographic nonunion in 13.8%. Others have reported nonunion rates of 0% to 44% (3,4,7,8). Infections and dehiscence have been reported in the range of 0% to 15% for HIPJ arthrodesis (3,9,10). However, many studies regarding HIPJ arthrodesis tend to focus on nonunion rates and to not report the infection rates (5,7,8). The reoperation rates have been reported at 16% to 40% (7,11). The high complication rates of our study might have resulted from patient selection. Our population included DM in 26.3% of patients, PN in 31.6%, and ulcerations in 15.1%. Other studies have reported results in patients with pes cavus, hereditary sensory motor neuropathy, spina bifida, cerebral palsy, poliomyelitis, traumatic arthritis, osteoarthritis, systemic arthritides, and hallux abductus interphalangeus deformities. However, very few have evaluated the outcomes of HIPJ arthrodesis in patients with DM (5,7,11). The oversampling of patients with DM in the present study could have increased the complication rates because poorly controlled and complicated DM have been shown to be significant risk factors for postoperative complications (12–14). In our primary analysis, the fixation technique, when dichotomized into single screw and other fixation, was not associated with having 1 complication in our study. In our secondary outcomes, in which fixation was categorized into 4 groups (crossed screws, single screw, crossed Kirchner wires, and other), and the outcome
was specific to each complication, fixation was associated with infection and reoperation on multivariate analysis. However, the stability of the analysis could be in question, as evidenced by the large 95% CI. Although our primary analysis was performed to achieve statistically meaningful results, this might have masked some differences. Previous studies of the adjacent joint, the first metatarsophalangeal joint, have also reported no difference with the fixation technique (15). Furthermore, the complication rates differed by institution. Also, the preoperative comorbidities were significantly different among the 4 sites and this site difference remained after logistic regression analysis. However, the fixation technique did not differ among the sites. This might imply that the complications were largely dependent on the preoperative medical status, such as the presence of PN, and less on the fixation technique. Conceivably, all surgeons believed they used adequate fixation for the procedure at surgery and, thus, bone healing was affected by patient health and patient selection. However, when fixation was expanded to 4 categories, the single screw technique resulted in lower infection and reoperation rates than either crossed Kirschner wires or other fixation techniques but not crossed screws (Table 6). This does seem to support the use of single screw fixation rather than crossed Kirschner wires. In the present study, PN was associated with increased complications (OR 2.7, 95% CI 1.1 to 7.4) and infection (OR 10.6, 95% CI 3.8 to
Table 6 Odds ratio estimates for infection and reoperation (N ¼ 152)* Odds Ratio Infection Crossed Kirschner wires versus single screw Crossed Kirschner wires versus other Crossed Kirschner wires versus crossed screws Other versus single screw Crossed screws versus single screw Other versus crossed screws PN Reoperation Crossed Kirschner wires versus single screw Crossed Kirschner wires versus other Crossed Kirschner wires versus crossed screws Other versus single screw Crossed screws versus single screw Other versus crossed screws DM
Estimate 95% Confidence Intervals 5.41 0.61 1.13 8.90 4.79 1.86 10.61
(1.44 (0.12 (0.22 (2.12 (1.00 (0.34 (3.82
to to to to to to to
20.82) 2.96) 6.22) 38.83) 21.72) 10.90) 32.44)
6.16 0.77 1.88 7.97 3.28 2.43 3.03
(2.17 (0.20 (0.49 (2.51 (0.97 (0.59 (1.30
to to to to to to to
18.10) 2.98) 7.59) 26.80) 10.50) 10.80) 7.20)
Abbreviations: DM, diabetes mellitus; PN, peripheral neuropathy. On secondary outcome analysis comparing expanded fixation techniques (single screw, crossed Kirschner wire, crossed screws, and other), multivariate analysis identified fixation technique and PN as significant predictors of infection (p < .01 and p < .01, respectively). The fixation technique and DM were significant predictors of reoperation (p < .01 and p < .01 respectively). * Total of 152 patients with 152 arthrodesis procedures (only 1 side was selected by random selection in patients with bilateral procedures).
Fig. 3. Neuropathic patient with prominent screw visible through the open wound on the distal aspect of the hallux. The single screw was removed uneventfully. However, hardware removal was identified as the most common reason for reoperation, occurring in 17.8% of patients.
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32.4). Others have also found PN to be associated with complications in the foot and ankle, specifically bone healing complications. In a study that evaluated bone healing complications in patients with DM, 26 of 59 patients with PN (44%) had 1 bone healing complications (16). PN was the single most significant factor that affected bone healing compared with other factors such as glycosylated hemoglobin, peripheral vascular disease, tobacco use, history of ulceration, surgical time, and BMI (16). HIPJ arthrodesis has been used for treatment or as a prophylactic measure for ulcerations once nonoperative therapies have failed (17). In contrast, others have considered open ulcerations to be a contraindication for HIPJ fusion (5). Others have suggested Keller arthroplasty (18) or HIPJ arthroplasty (19) for hallux interphalangeal joint ulcerations. Given the high complications with HIPJ arthrodesis in the presence of PN, arthroplasty might be a reasonable alternative for these patients because it does not demand fusion of bone. The present study did not investigate the occurrence of re-ulceration in patients with ulcerations nor did our study allow for a direct comparison. Many studies have used vague definitions of nonunion. Therefore, the incidence of nonunion might not be easily comparable across studies. In a survey of 444 surgeons, nonunion definitions ranged from the absence of union at 2 to 12 months, and fewer than one half of the respondents used all the following criteria: cortical continuations, callus size, progressive loss of fracture line, ability to bear weight, and pain with palpation of fracture site (20). Our study used very specific criteria for delayed union and nonunion. This allowed for clear interpretation of the delayed union and nonunion definitions. Furthermore, our study also used separate clinical and radiographic nonunion definitions. Clinical and radiographic union is not interchangeable, which can be seen in Table 3. Of the 76 patients with radiographic evidence of union, 2 had clinical nonunion, and 10 of the 27 patients with radiographic nonunion had clinical union. Several limitations of the present study could have contributed to the results. First, owing to the retrospective nature of our study, we know that the fixation choice by each surgeon was not independent of other factors. Naturally, higher risk patients might have had more stable constructs. Some covariates were adjusted for in the regression analysis, but many other factors can play a role in the surgeon’s decision-making. The multicenter design, including many different surgeons, however, reduced any single surgeon’s impact in the present study. Second, our sample size might not have been large enough to build a stable model to compare the different fixation techniques. Thus, our primary outcome combined the fixation type into single screw versus others and only studied presence of any complications. Fixation was not found to be significantly associated with having 1 complication, but it was significantly associated with both reoperation and infection when the fixation groups were further categorized into 4 groups. The validity of this finding is, however, in question, because the 95% CIs were large. Third, our study contained a large number of patients with insufficient data to determine whether radiographic union was present. Although clinical union was included to capture patients with >6 weeks of follow-up, 27% of patients either did not have a long enough follow-up period or the documentation was insufficient to determine whether union had occurred. Despite the limitations, the present study had the largest population thus far used to investigate HIPJ fusion procedures (the second
largest was Shives and Johnson [3] in 1980, with 139 patients). The present study has demonstrated the high postoperative complication rates seen with HIPJ arthrodesis. The fixation technique was not associated with overall complication rate. However, PN and study site were associated with the incidence of postoperative complications. When treated individually and separately, PN and fixation type were associated with infection and DM and fixation type were associated with reoperation. These data seem to support the use of single screw fixation, but this result must be taken with caution and larger randomized trials are warranted to validate our findings. Acknowledgments We thank Yolanda Munoz Maldonado, PhD, biostatistician, Baylor Scott and White, Temple, TX. References 1. Moyer J, Lowery C, Knox J. Hallux IPJ fusion. Clin Podiatr Med Surg 21:51–64, 2004. 2. O’Donoghue D, Stauffer R. An improved operative method for obtaining bony fusion of the great toe. Surg Gynecol Obstet 76:498–500, 1943. 3. Shives TC, Johnson KA. Arthrodesis of the interphalangeal joint of the great toedan improved technique. Foot Ankle 1:26–29, 1980. 4. Langford JH, Fenton CF III. Hallux interphalangeal arthrodesis. J Am Podiatry Assoc 72:155–157, 1982. 5. Derner R, Meyr AJ. Hallux interphalangeal joint arthrodesis. J Foot Ankle Surg 48:408–410, 2009. 6. Sharon SM, McClain J. An alternative fixation technique when performing hallux interphalangeal joint fusions. J Foot Surg 24:132–135, 1985. 7. Asirvatham R, Rooney RJ, Watts HG. Stabilization of the interphalangeal joint of the big toe: comparison of three methods. Foot Ankle 13:181–187, 1992. 8. Faraj AA. Modified Jones procedure for post-polio claw hallux deformity. J Foot Ankle Surg 36:356–359, 1997. 9. Brutus JP, Palmer AK, Mosher JF, Harley BJ, Loftus JB. Use of a headless compressive screw for distal interphalangeal joint arthrodesis in digits: clinical outcome and review of complications. J Hand Surg Am 31:85–89, 2006. 10. Kimmel HM, Garrow S. A comparison of end-to-end versus “V” arthrodesis procedures for the correction of digital deformities. Clin Podiatr Med Surg 13:239– 250, 1996. 11. Dhukaram V, Roche A, Walsh H. Interphalangeal joint fusion of the great toe. Foot Ankle Surg 9:161–163, 2003. 12. Myers TG, Lowery NJ, Frykberg RG, Wukich DK. Ankle and hindfoot fusions: comparison of outcomes in patients with and without diabetes. Foot Ankle Int 33:20–28, 2012. 13. Perlman MH, Thordarson DB. Ankle fusion in a high risk population: an assessment of nonunion risk factors. Foot Ankle Int 20:491–496, 1999. 14. Younger AS, Awwad MA, Kalla TP, de Vries G. Risk factors for failure of transmetatarsal amputation in diabetic patients: a cohort study. Foot Ankle Int 30:1177–1182, 2009. 15. Hyer CF, Scott RT, Swiatek M. A retrospective comparison of four plate constructs for first metatarsophalangeal joint fusion: static plate, static plate with lag screw, locked plate, and locked plate with lag screw. J Foot Ankle Surg 51:285–287, 2012. 16. Shibuya N, Humphers JM, Fluhman BL, Jupiter DC. Factors associated with nonunion, delayed union, and malunion in foot and ankle surgery in diabetic patients. J Foot Ankle Surg 52:207–211, 2013. 17. Wukich DK. Current concepts review: diabetic foot ulcers. Foot Ankle Int 31:460– 467, 2010. 18. Armstrong DG, Lavery LA, Vazquez JR, Short B, Kimbriel HR, Nixon BP, Boulton AJ. Clinical efficacy of the first metatarsophalangeal joint arthroplasty as a curative procedure for hallux interphalangeal joint wounds in patients with diabetes. Diabetes Care 26:3284–3287, 2003. 19. Lew E, Nicolosi N, McKee P. Evaluation of hallux interphalangeal joint arthroplasty compared with nonoperative treatment of recalcitrant hallux ulceration. J Foot Ankle Surg, 2014 Nov 13. http://dx.doi.org/10.1053/j.jfas.2014.08.014 [Epub ahead of print]. 20. Bhandari M, Guyatt GH, Swiontkowski MF, Tornetta P III, Sprague S, Schemitsch EH. A lack of consensus in the assessment of fracture healing among orthopaedic surgeons. J Orthop Trauma 16:562–566, 2002.