Pyrocarbon Proximal Interphalangeal Joint Arthroplasty: Minimum Five-Year Follow-Up

SCIENTIFIC ARTICLE

Pyrocarbon Proximal Interphalangeal Joint Arthroplasty: Minimum Five-Year Follow-Up David R. Dickson, MBBS,* David Nuttall, PhD,* Adam C. Watts, BSc, MBBS,* Sumedh C. Talwalkar, MBBS,* Mike Hayton, MBBS,* Ian A. Trail, MD*

Purpose To report the outcomes, complications, and survivorship of pyrocarbon proximal interphalangeal joint arthroplasty at a minimum of 5-year follow-up. Methods A review of 97 implants in 72 consecutive patients from our joint arthroplasty database was undertaken. Patient demographics, complications, further surgery, and implant revision were recorded. Objective outcome was assessed by grip strength, range of motion, and radiological assessment of alignment, loosening, and subsidence. Subjective outcome was assessed by Patient Evaluation Measure; Quick Disabilities of the Arm, Shoulder, and Hand score; and visual analog scores (0, best; 10, worst) for appearance, satisfaction, and pain. Results Diagnosis was osteoarthritis in 60 joints, rheumatoid arthritis in 12 joints, psoriatic arthritis in 11 joints, and trauma in 14 joints. The average follow-up was 118 months (range, 60e164 months). The mean arc of motion was 35
(range, 0
to 90
). There was no difference in grip strength between operated and nonoperated side. Of the 97 implants, 36 required additional surgery, of which 14 were revised and 22 required reconstruction around a retained implant. The average Patient Evaluation Measure and Quick Disabilities of the Arm, Shoulder and Hand scores were 33 (range, 10e69) and 35 (range, 0e93), respectively. Mean visual analog scores for pain, satisfaction, and appearance were 2 (range, 0e8), 7 (0e10), and 8 (0e10), respectively. All implants had a lucent line with nearly all classified as either Herren grade 2 or 3. Progressive loosening was seen in 48% of implants. Implant survival as assessed by KaplaneMeier was 85% at both 5 and 10 years. Conclusions Good pain relief and maintenance of preoperative arc of motion was achieved with no major deterioration over time. Most implant revisions were performed within 24 months of the index procedure. Currently progressive loosening was not translated into revision surgery. Implant revision rate was higher than with other prostheses. (J Hand Surg Am. 2015;-(-):-e-. Copyright Ó 2015 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic IV. Key words Arthroplasty, outcome, proximal interphalangeal joint, pyrocarbon, pyrolytic carbon.

From the *Upper Limb Unit, Wrightington Hospital, Wigan, Lancashire, United Kingdom. Received for publication June 11, 2015; accepted in revised form August 10, 2015. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Corresponding author: David R. Dickson, MBBS, Upper Limb Unit, Wrightington Hospital, Hall Lane, Appley Bridge, Wrightington, Wigan WN6 9EP, United Kingdom; e-mail: [email protected]. 0363-5023/15/---0001$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2015.08.009

P

ROXIMAL INTERPHALANGEAL (PIP) JOINT inflammatory

and noninflammatory arthritis is common. Although many patients remain largely asymptomatic despite radiographic changes, some may have pain, stiffness, or disability that compromises hand function.1 Often, initial treatment is with activity modification, simple analgesics, anti-inflammatories, and intra-articular steroid injections.2 Operative intervention consists of either arthrodesis or arthroplasty. The loss of

Ó 2015 ASSH

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PYROCARBON PIP JOINT ARTHROPLASTY

motion created by an arthrodesis, particularly in the ring and little fingers, may negatively impact hand function.3 Arthroplasty aims to maximize motion, relieve stiffness, and improve function while relieving pain.4 There are multiple implants from flexible hinges to constrained implants and surface replacements.5 The main materials used are either silicone, or metal and polyethylene, or pyrolytic carbon (pyrocarbon). Pyrocarbon is a durable, strong, inert, and wearresistant biomaterial with an elastic modulus similar to that of cortical bone.6e8 These properties have resulted in low rates of periprosthetic fracture, no evidence of inflammatory reaction, wear debris, or particulate synovitis.7 Pyrocarbon implants are designed to be press fit and to allow for bone in-growth.8,9 However, clinical evidence has failed to substantiate this, and a fibrous interface usually develops.7 The aim of this study was to report the outcome of pyrocarbon PIP joint arthroplasty at a minimum of 5 years of follow-up from a single unit. The incidence and causes of repeat surgeries, revision, and complications were examined. Data were compared with the previously published 2-year outcomes.10

TABLE 1. System10

MATERIALS AND METHODS A retrospective cohort study was undertaken of consecutive patients who underwent pyrocarbon PIP joint arthroplasty at a single institution with a minimum of 5 years of follow-up. Local ethics committee approval was obtained. There were no conflicts of interest regarding the study design; no external funding was received, and none of the authors have a financial relationship with the implant or manufacturer. The patients represent a previously published cohort and had been identified through a departmental database, operative records, and the clinical coding department. Medical records including operation notes and clinical notes were reviewed. Patient demographics and data on surgical approach, further surgery, and revision surgery were recorded. Revision was defined as removal of the implant for any reason. All patients were invited for clinical and radiological review. Patients unable to attend completed a questionnaire and/or underwent a telephone consultation. This group of patients underwent only subjective evaluation along with questions about need for further surgery. All assessments were compared with scores and values taken at a minimum of 2-year follow-up mark.

Grade

Description

0

No radiolucent line around the implant on plain radiograph

1

Radiolucent line present measuring up to 0.5 mm in width at any point around the implants

2

Radiolucent line greater than 0.5 mm in width at any point around the implant

3

Macroscopic migration of the implant increased angulation of greater than 5


FIGURE 1: A flowchart showing the study population, loss to follow-up, and the proportion undergoing different assessments.

from the angle achieved on full flexion. Passive motion was assessed when an active flexion or extension deficit was noted. Grip strength was assessed on both hands with a Jamar dynamometer (Jamar, Preston, MI). All measurements were taken on the second smallest setting with the mean of the 3 recordings used to maximize accuracy. Complications were categorized early (< 6 months) or late ( 6 months) and defined as implant loosening, implant fracture, periprosthetic fracture, joint squeaking, wound problems, infection, tendon problems, need for further surgery, and revision surgery. Subjective assessment The subjective outcome was assessed using the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) questionnaire11 and the Patient Evaluation Measure (PEM).12 Both are validated outcome measures11,13 with lower values corresponding to better results. A 10-point visual analog scale (VAS) was used to evaluate pain, patient satisfaction with surgery, and

Objective assessment Active flexion and extension of the PIP joint was performed with a hand-held goniometer. Arc of motion was calculated by subtracting any flexion contracture J Hand Surg Am.

Radiological Loosening Classification

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35 (0e90)

Early Complications (12 Digits)

30 (0e90)

20 (0e35)

25 (0e85) 15 (10e80)

20 (0e75)

45 (0e70) 40 (0e60)

35 (0e80)

TABLE 3. Early and Late Postoperative Complications

30 (0e90)

Average Arc of Motion at Minimum 2-y Follow-Up (Range)

Average Arc of Motion at Minimum 5-y Follow-Up (Range)

PYROCARBON PIP JOINT ARTHROPLASTY

Late Complications (54 Digits)

Phalangeal fracture 3

Stiffness 19

Dislocation 2

Swan neck 9

Squeak 3

Dislocation 4

Infection 1

Collateral rupture 3

Heterotopic bone 1

Aseptic loosening 4

Boutonniere 1

Progressive radiological loosening 15

23 (0e85)

25 (0e85)

5 (36)

54 (56)

appearance of the digit after surgery. Patients selected a point along the scale that corresponded to their own assessment of each criterion. For all 3 VAS, the best possible score was zero. Finally, all patients were asked: “Would you undergo the same operation again?” Radiological evaluation Patients who followed up had posteroanterior and lateral radiographs taken, which were compared with initial postoperative and all follow-up radiographs. Radiological loosening was classified using a modification of the system described by Herren et al14 (Table 1). The coronal and sagittal alignment of the components was measured in relation to the long axis of the bone. We used the digital radiology imaging system (Centricity PACS, GE Systems, Bucks, UK). An investigator who had not been involved at any point in the patient’s care made all these assessments.

14 (14) 27:70 57 (24e79)

Statistical analysis Normally distributed data were described using means, ranges, and standard deviation when appropriate. Nonparametric data were assessed using median, range, and interquartile range when appropriate. Comparative data were assessed with Wilcoxon signed rank tests. Implant survival was analyzed with KaplaneMeier. Cox regression analysis was used to assess factors responsible for implant revision. Statistical significance was set at a P value of less than .05. RESULTS There were 97 PIP joint pyrocarbon arthroplasties in 72 consecutive patients undertaken by 5 dedicated hand surgeons (see Fig. 1). Nine patients (14 implants) were lost to follow-up over the study period. At the time of the last clinical assessment, none of these 14 implants had either undergone or had further surgery planned.

Total

97

3 (21)

7 (7)

20 (0e35) 10 (91) 1 (9)

50 (24e62)

8:6

41 (35e64) 11

Posttraumatic arthritis

Psoriatic arthritis

14

11:0

0

0 (0e20) 9 (75)

2 (14)

30 (0e85) 30 (50)

1 (8)

4 (7) 9 (15)

0:12

62 (36e79)

47 (32e72)

60

Rheumatoid arthritis

Osteoarthritis

12

8:52

1 (8)

Late Complications (%) Revisions (Percent of Implants) Sex (Male: Female) Age (Range, y) Number of Cases Diagnosis

TABLE 2.

Demographics and Outcome by Diagnosis

Early Complications (%)

Average Preoperative Arc of Movement (Range)

Retained suture 1

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TABLE 4.

Number and Indications for Further Surgery and Implant Revisions

Further Surgery—Implant Retained (22 Digits)

Stiffness (15 joints)

Implant Revision (14 Digits)

Arthrolysis/tenolysis 9

Instability (4 joints)

All revised to silicone implant

Percutaneous accessory ligament release 3

Aseptic loosening (4 joints)

All revised to silicone implant

Manipulation under anesthesia 3 FDS tenodesis for swan-neck 4 Deformity (6 joints)

Central slip advancement for boutonniere 1 Collateral ligament reconstruction 1

Other (1 joint)

Removal suture 1

1 revised to arthrodesis Stiffness (3 joints)

1 revised to silicone implant 1 revised to silicone implant, subsequent arthrodesis

Collateral instability (1 joint)

Revised to arthrodesis

Angular deformity (1 joint)

Revised to arthrodesis

Infection (1 joint)

2-stage revision to arthrodesis

FDS, flexor digitorum superficialis.

FIGURE 2: KaplaneMeier analysis of proximal interphalangeal pyrocarbon implant survival.

A further 26 patients (32 implants) were only assessed via questionnaire or telephone consultation because of either medical problems or logistical problems attending assessment. Thirty-seven patients with 51 implants returned for evaluation. This cohort was used for the description of clinical and radiological parameters in the data analysis. Complications and implant survival were described in relation to the total 97 implants. J Hand Surg Am.

The average follow-up time was 118 months (range, 60e164 months). The mean age at the time of surgery was 57 years (range, 24e79 years). Fifty-one patients (71%) were women. The dominant hand was involved in 41 (42%) implants. The primary diagnosis was osteoarthritis in 60 joints (60%), rheumatoid arthritis in 12 joints (13%), psoriatic arthritis in 11 joints (8%), and trauma in 14 joints (19%). There were 24 index, 31 r

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PYROCARBON PIP JOINT ARTHROPLASTY

middle, 32 ring, and 10 little fingers involved. The arthroplasty was performed through a central tendon split dorsal approach in 46 cases, dorsal Chamay in 45, and a lateral approach in 6.

TABLE 5. Objective Scores at a Minimum of 2 and 5 y Follow-Up Outcome Measure

Objective assessment The objective outcomes (overall and separated into underlying diagnosis) are shown in Table 2. Overall, the average arc of motion was 35
(range,
0 to 90
), average extension 18
(range, 20
to þ50
), and average flexion 53
(range, 10
to þ90
). Nine joints (11%) had hyperextension and 25 joints (30%) had a greater than 20
extensor lag. Twelve joints (15%) had greater than 60
of flexion. Ten joints (12%) had no measurable movement. On paired nonparametric analysis, there was no notable change in range of motion between preoperative and either 2-year (P ¼ .48) or 5-year (P ¼ .36) follow-up assessments. The grip strength was a mean of 20 kg on both the ipsilateral and contralateral hands. This represents a statistically significant decrease from 27 kg at the 2-year follow-up (P ¼ .03). There were 12 early (< 6 months) and 54 late (> 6 months) complications. The type and number of each complication is shown in Table 3. All the phalangeal fractures were noted at the time of surgery. There were no implant fractures. Of the 3 squeaking joints, 2 resolved spontaneously. The remaining squeaky joint showed no evidence of loosening or wear and remained in situ. Further surgery without revising the implant was undertaken in 22 joints with implant revision undertaken in 14. The average time to revision was 19 months. The indication and type of further surgery undertaken is shown in Table 4. Implant survival as assessed by KaplaneMeier revealed 85% ( 7%, 95% CI) survival at both 5 and 10 years (Fig. 2). Revision of the implant for any cause was used as the end point in this assessment. All but 2 of the revisions occurred within the first 24 months of the index procedure. The reasons for revision were varied and due to instability, aseptic loosening, and stiffness. Cox regression analysis identified only 1 factor, surgery to the ring finger that was related to implant revision, with 8 revision surgeries in 31 digits and survival at 28 months of 75%. Patient age, sex, diagnosis, and immediate postoperative alignment were not related to implant revision.

5y

PEM

34 (10e64)

33 (10e69)

.34

DASH

22 (10e48)

35 (0e93)

.75

Pain

0 (0e7)

2 (0e8)

.60

Satisfaction

8 (0e10)

7 (0e10)

.31

Appearance

4 (0e10)

4 (0e10)

.25

74%

71%

.48

Same surgery

P Value

FIGURE 3: Average scores on the 10-item PEM questionnaire.12

over time. The mean scores for the individual components of the PEM score are shown in Figure 3. Radiological assessment None of the implants showed evidence of subluxation, dislocation, or fracture on follow-up radiographs. A lucent periprosthetic line was visible on all implants. The grades, alignment, and comparison with previous radiographs are shown in Table 6. Although progressive lucency and migration has been seen, there were no impending fractures or any currently requiring further surgery. DISCUSSION PIP joint arthroplasty has been used for several decades to maximize function by retaining motion and relieving pain. Replacement surgery is relatively infrequent, with many surgeons having limited experience with the different prosthetic designs and materials available.7 High complication rates15,16 with reoperation rates of 20%17 have been reported that would be deemed unacceptable in lower limb arthroplasty.7 The National Joint Registry in the United Kingdom as with most

Subjective assessment The average VAS scores for pain, satisfaction, and appearance; the PEM and QuickDASH scores; along with an expression of whether the patient would undergo the same operation again are shown in Table 5. There has been no notable change in these scores J Hand Surg Am.

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PYROCARBON PIP JOINT ARTHROPLASTY

TABLE 6.

Assessment of Prosthetic Lucency and Alignment Lucency, number

Alignment Sagittal,
(Range)

Grade 1

Grade 2

Grade 3

Progression From 2 to 5 y

Proximal

2

29

20

48%

2 (0e26)

3 (0e15)

23%

Distal

1

30

20

48%

3 (0e13)

4 (0e22)

39%

Component

countries has not expanded to include small joint arthroplasty. Until that occurs cohort study reports will be the mainstay of providing meaningful data. This study has clinical relevance because it provides follow-up data from a large cohort10 with a minimum of 5 years since surgery and the ability to compare both preoperative data with 2 different time points. The pyrocarbon implant is a nonconstrained surface replacement and requires good ligamentous support making noninflammatory arthritis the ideal indication. There were 7 cases of joint dislocation and 3 phalangeal fractures in this series. Although these were not associated with underlying diagnosis or seniority or previous experience of the surgeon, they most likely represent technical errors and demonstrate that undertaking a PIP joint arthroplasty requires a meticulous surgical technique. It is important to avoid aggressive broaching or forceful implant placement to prevent fracture of the phalanx. The ligaments need to be thoroughly assessed intraoperatively. If they are found to be deficient, then we advocate using a constrained silicone prosthesis. In our experience, it is a fine balancing act in allowing sufficient space for the implant while minimizing bone resection to preserve the ligaments. The functional range of motion in the PIP joint has been the focus of 2 studies.18,19 The required degree of flexion tends to increase from the index to little fingers.18 Most function is restored if there is less than 20
of extension lag and the joint can achieve over 80
of flexion.18,19 In our series, 9 joints (11%) had hyperextension, 25 joints (30%) had a greater than 20
extensor lag, and 12 (15%) had at least 80
of flexion. This may help explain why some patients reported functional difficulties, although there was no correlation between range of motion and either of the patient-rated outcome scores. Herren et al14 raised concerns about osseointegration of pyrocarbon implants, and questions about loosening have remained. A nonprogressive radiolucent line of 0.5 to 1 mm is normal and due to the coating of the implant. In our earlier study, we cast this proposition into doubt, as the line is frequently not initially visible on the immediate postoperative radiograph. This may, however, be due to the absence of bone apposition against the implant immediately after reaming.10 However, in this J Hand Surg Am.

Coronal, (Range)




Progression From 2 to 5 y

follow-up study, we noticed progressive lucency in 15 components with evidence of migration in 12. Although there is currently no evidence that it affects the clinical outcome, with only 4 components revised for loosening, these 15 implants need careful monitoring. The shape of the KaplaneMeier curve was not consistent with progressive loosening of an implant, in which an increase in revision rate with time would be anticipated. The curve showed early failures that may represent technical problems such as soft-tissue balancing. The comparative outcomes of PIP joint arthroplasty from pyrocarbon, silicone, and cobalt-chrome on polyethylene are shown in Appendix A, available on the Journal’s Web site at www.jhandsurg.org. Outcome measures are similar regardless of the implant used. This is supported by a systematic review36 and 2 nonrandomized studies27,29 comparing pyrocarbon and silicone arthroplasty in the PIP joint. These 3 studies found satisfactory pain relief, range of motion, and grip strength. The pyrocarbon implant, however, was associated with a higher revision rate and need for salvage procedures. Our study found that pyrocarbon implants reliably relieved pain but arc of motion and grip strength did not improve from preoperative measurements. This is in keeping with the studies shown in Appendix A. Our study provides data at a separate follow-up point showing that pain relief, arc of motion, PEM, and QuickDASH scores did not alter in a major way over time. The implant revision incidence of 14% in our study is greater than that shown for silicone implants29 (3%, mean, 5.1 years) or cemented avanta34 (4%, minimum 3-year follow-up). This incidence may yet rise further if the 15 implants with progressive loosening require implant revision. The main limitations of our study are its retrospective nature, the variety of surgical approaches used, and the heterogeneous case mix. We were only able to undertake clinical and radiological assessment on 53% of implants because 7% had died and 7% could not be located. The remaining 33% were only followed up by questionnaire without clinical and radiological assessment. The surgery was performed on patients in the United Kingdom, and so our results may not be reproducible in populations with different genetic and cultural backgrounds. r

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PYROCARBON PIP JOINT ARTHROPLASTY

Although our results reveal excellent pain relief and implant survival, there is a wide unpredictable variation in range of motion with only 71% of patients stating that they would undergo the procedure again. In our experience, these implants are associated with a higher rate of secondary surgery compared with silicone implants, with some of implants showing evidence of progressive loosening.

18. Bain GI, Polites N, Higgs BG, Heptinstall RJ, McGrath AM. The functional range of motion of the finger joints. J Hand Surg Eur. 2015;40(4):406e411. 19. Hume MC, Gellman H, McKellop H, Brumfield RH. Functional range-of-motion of the joints of the hand. J Hand Surg Am. 1990;15(2):240e243. 20. Mashhadi SA, Chandrasekharan L, Pickford MA. Pyrolytic carbon arthroplasty for the proximal interphalangeal joint—results after minimum of 3 years follow-up. J Hand Surg Eur. 2012;37(6): 501e505. 21. Hutt JRB, Gilleard O, Hacker A, Citron N. Medium-term outcomes of pyrocarbon arthroplasty of the proximal interphalangeal joint. J Hand Surg Eur. 2012;37(6):497e500. 22. Heers G, Springorum HR, Baier C, Götz J, Grifka J, Renkawitz T. Proximal interphalangeal joint replacement with an unconstrained pyrocarbon prosthesis (Ascension(R)): a long-term follow-up. J Hand Surg Eur. 2013;38(6):680e685. 23. Tägil M, Geijer M, Abramo A, Kopylov P. Ten years’ experience with a pyrocarbon prosthesis replacing the proximal interphalangeal joint. A prospective clinical and radiographic follow-up. J Hand Surg Eur. 2014;39(6):587e595. 24. McGuire DT, White CD, Carter SL, Solomons MW. Pyrocarbon proximal interphalangeal joint arthroplasty: outcomes of a cohort study. J Hand Surg Eur. 2012;37(6):490e496. 25. Bravo CJ, Rizzo M, Hormel KB, Beckenbaugh RD. Pyrolytic carbon proximal interphalangeal joint arthroplasty: results with minimum two-year follow-up evaluation. J Hand Surg Am. 2007;32(1):1e11. 26. Wijk U, Wollmark M, Kopylov P, Tagil M. Outcomes of proximal interphalangeal joint pyrocarbon implants. J Hand Surg Am. 2010;35(1):38e43. 27. Daecke W, Kaszap B, Martini AK, Hagena FW, Rieck B, Jung M. A prospective, randomized comparison of 3 types of proximal interphalangeal joint arthroplasty. J Hand Surg Am. 2012;37(9): 1770e1779. 28. Branam BR, Tuttle HG, Stern PJ, Levin L. Resurfacing arthroplasty versus silicone arthroplasty for proximal interphalangeal joint osteoarthritis. J Hand Surg Am. 2007;32(6):775e788. 29. Swanson AB, Maupin BK, Gajjar NV, Swanson GG. Flexible implant arthroplasty in the proximal interphalangeal joint of the hand. J Hand Surg Am. 1985;10(6 Pt 1):796e805. 30. Lin HH, Wyrick JD, Stern PJ. Proximal interphalangeal joint silicone replacement arthroplasty: clinical results using an anterior approach. J Hand Surg Am. 1995;20(1):123e132. 31. Takigawa S, Meletiou S, Sauerbier M, Cooney WP. Long-term assessment of Swanson implant arthroplasty in the proximal interphalangeal joint of the hand. J Hand Surg Am. 2004;29(5): 785e795. 32. Linscheid RL, Murray PM, Vidal MA, Beckenbaugh RD. Development of a surface replacement arthroplasty for proximal interphalangeal joints. J Hand Surg Am. 1997;22(2):286e298. 33. Johnstone BR, Fitzgerald M, Smith KR, Currie LJ. Cemented versus uncemented surface replacement of the proximal interphalangeal joint with a mean 5-year follow-up. J Hand Surg Am. 2008;33(5):726e732. 34. Jennings CD, Livingstone CD. Surface replacement arthroplasty of the proximal interphalangeal joint using the PIP-SRA implant: results, complications and revisions. J Hand Surg Am. 2008;33(9): 1565e1e1565e11. 35. Luther C, Germann G, Sauerbier M. Proximal interphalangeal joint replacement with surface replacement arthroplasty (SR-PIP): functional results and complications. Hand (NY). 2010;5(3): 233e240. 36. Chan K, Ayeni O, McKnight L, Ignacy TA, Farrokhyar F, Thoma A. Pyrocarbon versus silicone proximal interphalangeal joint arthroplasty: a systematic review. Plast Recon Surg. 2013;131(1):114e124.

REFERENCES 1. Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Aliabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: the Framingham study. Am J Epidemiol. 2002;156(11):1021e1027. 2. National Institute for Health and Care Excellence. Osteoarthritis, Care and Management in Adults. NICE clinical guideline 177. London, United Kingdom: National Institute for Health and Care Excellence; 2014. 3. Pellegrini VD Jr, Burton RI. Osteoarthritis of the proximal interphalangeal joint of the hand: arthroplasty or fusion? J Hand Surg Am. 1990;15(2):194e205. 4. Murray PM. Prosthetic replacement of the proximal interphalangeal joint. Hand Clin. 2006;22(2):201e206. 5. Adams J, Ryall C, Pandyan A, et al. Proximal interphalangeal joint replacement in patients with arthritis of the hand: a meta-analysis. J Bone Joint Surg Br. 2012;94(10):1305e1312. 6. Haubold AD. On the durability of pyrolytic carbon in vivo. Med Prog Tech. 1994;20(3e4):201e208. 7. Daecke W, Veyel K, Wieloch P, Jung M, Lorenz H, Martini MK. Osseointegration and mechanical stability of pyrocarbon and titanium hand implants in a load-bearing in vivo model for small joint arthroplasty. J Hand Surg Am. 2006;31(1):90e97. 8. Cook SD, Klawitter JJ, Weinstein AM. The influence of implant elastic modulus on the stress distribution around LTI carbon and aluminum oxide dental implants. J Biomed Mater Res. 1981;15(6): 879e887. 9. Cook SD, Beckenbaugh RD, Weinstein AM, Klawitter JJ. Pyrolite carbon implants in the metacarpophalangeal joints of baboons. Orthopedics. 1983;6(8):952e961. 10. Watts AC, Hearnden AJ, Trail IA, Hayton MJ, Nuttall D, Stanley JK. Pyrocarbon proximal interphalangeal joint arthroplasty: minimum two-year follow-up. J Hand Surg Am. 2012;37(5):882e888. 11. Beaton DE, Wright JG, Katz JN. Development of the QuickDASH: comparison of 3 item-reduction approaches. J Bone Joint Surg Am. 2005;87(5):1038e1046. 12. Macey AC, Burke FD, Abbott K, et al. Outcomes of hand surgery. J Hand Surg Br. 1995;20(6):841e855. 13. Dias JJ, Bhowal B, Wildin CJ, Thompson JR. Assessing the outcome of disorders of the hand. Is the patient evaluation measure reliable, valid, responsive and without bias? J Bone Joint Surg Br. 2001;83(2):235e240. 14. Herren DB, Schindele S, Goldhahn J, Simmen BR. Problematic bone fixation with pyrocarbon implants in proximal interphalangeal joint replacement: short-term results. J Hand Surg Am. 2006;31(6):643e651. 15. Drake ML, Segalman KA. Complications of small joint arthroplasty. Hand Clin. 2010;26(2):205e212. 16. Sweets TM, Stern PJ. Proximal interphalangeal joint arthroplasty. J Hand Surg Am. 2010;35(7):1190e1193. 17. Pritsch T, Rizzo M. Reoperations following proximal interphalangeal joint non-constrained arthroplasties. J Hand Surg Am. 2011;36(9): 1460e1466.

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PYROCARBON PIP JOINT ARTHROPLASTY

APPENDIX A.

Published Studies Showing Clinical and Functional Outcomes of PIP Joint Arthroplasty Number of Joints

Study

Preoperative Follow-Up Arc of Arc of Motion Motion

Follow-Up (Range)

Loosening

Dislocation

Complications

Pyrocarbon Mashhadi 201220

24

4 y (3e5 y)

36

46

3/16

1

Flexion contracture 5/24, squeaking 4/24, 1 dislocation

Hutt 201221

18

6.2 y (2.1e8.8 y)

40

45

Not assessed

0

2 persistent pain, 1 CRPS, 2 stiffness, 1 instability

Herren 200614

17

19 mo (12e27 mo)

34

42

17/17

0

None

Heers 2013

13

8.3 y (6.2e9.3 y)

46

9

7/13

0

2 swan-neck, 2 stiffness, 3 prosthetic migration

Tägil 201423

89

53

54

80%

0

2 deep infection, 1 aseptic loosening, 2 swan-necks

McGuire 201224

57

27 mo (12e70 mo)

30

66

Not assessed

0

6 stiffness, 11 swan-neck deformities, 3 boutonniere, 2 intraoperative fractures, 2 squeaking joints

Bravo 200725

50

37 mo (27e46 mo)

40

47

40%

2

1 retained suture, 2 stiffness, 1 painful bony spur, 1 extensor tendon triggering, 4 instability, 4 loosening, 1 limited function

Wijk 201026

53

23 mo (11e60 mo)

56

52

Not assessed

0

1 infection, 3 persistent pain, 1 stiffness, 1 swan-neck

Daecke 201227

18

35 mo (30e41 mo)

61

72%

3

3 subluxation/dislocation, 5 developed ossification, 1 ankylosis, 2 swan-neck deformity, 6 implant subsidence

Sweets 201016

31

5y

31

48%

5

19

19 mo (6e30 mo)

49

53

Feb. 19

2

43

54

5/424

56

7

22

28

Branam 2007

Not assessed

7 (2 loosening, 2 dislocations, 2 fractures, 1 wound problem)

Silicone Swanson 198529

424

5.1 y (1e16 y)

Pellegrini 19903

26

45 mo (1e9 y)

Not assessed

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22 implant fractures, 11 swan-neck, 16 ulna deviation, 3 dislocations, 3 infections 3 swan-neck, 11 extensor deficiency

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PYROCARBON PIP JOINT ARTHROPLASTY

APPENDIX A.

Published Studies Showing Clinical and Functional Outcomes of PIP Joint Arthroplasty (Continued)

Repeat Surgery

Revision Surgery

1 MUA, 3 arthrolysis

Functional Score

Preoperative Pain Score

Average Final Pain Score

Not assessed

Not assessed

0.9

Grip Strength

Implant Survival

15 kg

100%

1 tenolysis, 1 extensor tendon repair

2-1 amputation, 1 Not assessed arthrodesis

4.2 rest, 8.6 active

0 and 0

Not assessed

16/18

None

None

Not assessed

7.6 (4.6e9)

1.3 (0.8e2.8)

20.3 pre to 26 post

100%

2 tenolysis

None

Not assessed

Not assessed 5 pain free, 8 mild Not assessed emoderate pain

2 removal of implants for 6/89 (4 infection, 1 exchange arthrodesis, 2 for loosening, 2 revised implants down-sized for pyrocarbon stiffness, 2 littler tendon component) plasty for swan-neck 6 tenolysis, 7 FDS tenodesis, release for boutonniere

5. 4 to silastic, 1 to further pyrocarbon

DASH pre3.4 rest, 6 operative 40 activity (5e100) to 28 (0e59)

Not assessed

21 patients pain free at rest, 11 pain free on activity

Not assessed at final follow-up

Not assessed Not assessed Study inferred from 4.2/5 satisfaction on the Likert scale

100% 83/89

52/57

2 tenolysis, 1 release of 2 revised to lateral bands, 1 removal another pyrocarbon, 1 suture, 1 excision bony revised to spur, 3 soft-tissue silastic, 1 stabilization arthrodesis, 2 amputation

Not assessed

6

1

19 kg preoperative to 24 postoperative

44/50

2 tenolysis, FDS plasty for swan-neck

3 arthrodesis, 2 exchange of pyrocarbon implant, 1 revised to silastic

DASH preoperative 38 (5e86) to 28 (0e64)

3.1

0.4

19 kg preoperative to 21 kg postoperative

47/53

None

DASH 68 to 48 7 revised for aseptic loosening, restricted ROM or dislocation

8.1

2.7

Not assessed

11/18

Not assessed 2 manipulations

None

Not assessed

Not assessed

1.8

9 kg preoperative to 14 kg postoperative

10.9% underwent further 12 revision of Not assessed surgery. Implant implant, 1 exchange in most revised to fusion

Not assessed Complete pain relief in 98.3%

Not assessed

Not stated

Not assessed All enjoyed excellent pain relief

17 kg

None

Not assessed

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89.10%

100%

7.e3

PYROCARBON PIP JOINT ARTHROPLASTY

APPENDIX A.

Published Studies Showing Clinical and Functional Outcomes of PIP Joint Arthroplasty (Continued) Number of Joints

Study

Preoperative Follow-Up Arc of Arc of Motion Motion

Follow-Up (Range)

Loosening

Dislocation

Complications

2

5 implant fractures, 3 malrotation, 2 infections, 2 instability

Lin 199530

69

3.4 y (0.9e8.2 y)

44

46

Not assessed

Branam 200728

22

45 mo (7e110 mo)

53

52

None

Takigawa 200431

70

6.5 y (2.1e19.2 y)

25

30

8

Linscheid 199732

66

4.5 y (1e14 y)

35

47

Johnstone 200833

24

6y

40

49

Jennings 200834

45

3y

42

50

19

4y

47

55

Jennings 2008

41

3y

45

Luther 201035

24

2y

7 (1 fracture, 3 implant fractures, 1 deep infection, 1 superficial infection, 1 reduced sensation) 4

11 implant fracture, 4 instability, 1 infection

5

5 instability, 9 angular deformity, 7 stiffness, 1 loosening, 1 infection

0

1 deep infection, 7 stiffness, 1 loosening, 2 angular deformity

0

6 loosening, 11 stress shielding, 3 swan-neck, 2 stiffness, 1 flexion contracture

13/19

0

5 loosening

56

16/41

0

2 swan-neck

50

4

0

Cemented avanta No evidence of loosening 1

6 evidence of loosening

Uncemented avanta Johnstone 200833 34

Not assessed

CRPS, chronic regional pain syndrome; FDS, flexor digitorum superficialis; MUA, manipulation under anesthesia; ROM, range of motion.

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7.e4

PYROCARBON PIP JOINT ARTHROPLASTY

APPENDIX A.

Published Studies Showing Clinical and Functional Outcomes of PIP Joint Arthroplasty (Continued)

Repeat Surgery

Revision Surgery

Functional Score

Preoperative Pain Score

Not assessed 2 fusions, 1 infection, 1 impaction, 3 implant fractures

2 MUA

None

Grip Strength

Not assessed 67/69 relieved of pain

Not assessed

3

Not assessed

Not assessed

1.8

18 kg preoperative to 9 kg postoperative

9

Not assessed

Not assessed

2.4

Preoperative 9.1 to 11.3 kg postoperative

Not assessed

Not assessed Not assessed 56 pain free, 6 mild, 4 moderate

2 extensor complications, 2 amputations, 1 3 tenolysis, 2 skin grafts revision for malalignment 7 tenolysis, 1 swan-neck correction, 1 boutonniere correction

1 amputation, 6 revision of prosthesis

Not assessed

2 soft-tissue rebalancing

2 for loosening

Not assessed

5 for loosening

Not assessed

0

Average Final Pain Score

6.8

0.7

Not assessed 2 worse, 3 unchanged, 40 better

6

1.3

Implant Survival 62/69

90% at 9 y

63/66

Not assessed

23/24

Not assessed

40/42

Not assessed

14/19

16

16

Not assessed

Not assessed 4 worse, 37 better Not assessed

25/41

14

4

Not assessed

Not assessed

20/24

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3

Not assessed