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Comparison of Arthroplasties With or Without Bone Tunnel Creation for Thumb Basal Joint Arthritis: A Randomized Controlled Trial
SCIENTIFIC ARTICLE
Comparison of Arthroplasties With or Without Bone Tunnel Creation for Thumb Basal Joint Arthritis: A Randomized Controlled Trial Guus M. Vermeulen, MD, PhD, Kim R. Spekreijse, MD, Harm Slijper, PhD, Reinier Feitz, MD, Steven E. R. Hovius, MD, PhD, Ruud W. Selles, PhD
Purpose To compare the results for treatment of basal thumb osteoarthritis with and without the use of a bone tunnel at the base of the first metacarpal. Methods Women aged 40 years or older with stage IV osteoarthritis were randomized to 1 of 2 treatments. Patients were evaluated preoperatively and postoperatively at 3 and 12 months by assessing pain, outcome function measures, range of motion, strength, time to return to work or activities, satisfaction with the results, and complication rate. Results A total of 79 patients were enrolled in this study. Three months after surgery, PatientRated Wrist and Hand Evaluation pain and total scores were significantly improved in the bone tunnel group compared with the tunnel-free group. At 12 months, however, we found no significant differences for all outcome scores between groups. In addition, we observed no significant differences between groups in strength, duration to return to work or activities, patient satisfaction, and complication rates. Conclusions After the bone tunnel technique, patients have better function and less pain 3 months after surgery than do those in the nonebone tunnel group, which indicates faster recovery. However, 12 months after surgery, the functional outcome was similar. Because of faster recovery, we prefer the bone tunnel technique in the treatment of stage IV osteoarthritis. (J Hand Surg Am. 2014;:-e-. Copyright Ó 2014 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic I. Key words Ligament reconstruction, osteoarthritis, thumb, trapeziectomy, trapeziectomy with LRTI.
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base of the thumb can result in major impairment.1,2 Two recent randomized controlled trials (RCT) found no benefit of ligament reconstruction and tendon STEOARTHRITIS (OA) AT THE
From the Department of Hand and Wrist Surgery, Diakonessenhuis Utrecht; the Department of Plastic Surgery and Hand Surgery, Erasmus MC University Medical Center, Rotterdam; the Department of Rehabilitation Medicine, Rotterdam; and the Xpert Clinic Hilversum, Hilversum, The Netherlands. Received for publication December 22, 2013; accepted in revised form April 23, 2014. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Corresponding author: Guus M. Vermeulen, MD, PhD, Department of Hand and Wrist Surgery, Xpert Clinic Hilversum, Loosdrechtse Bos 15, 1213 RH Hilversum, The Netherlands; e-mail: [email protected]. 0363-5023/14/---0001$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2014.04.044
interposition (LRTI) after trapeziectomy in the long term (> 5 y) compared with trapeziectomy alone.3,4 However, because only 10% of patients in those studies had scaphotrapeziotrapezoid joint OA (stage IV OA according to the radiographic criteria of Eaton and Glickel5), these results primarily apply to stage II and III OA (radiographic OA only at the trapeziometacarpal joint). Because stage IV OA is characterized by more cartilage and ligament damage and metacarpal subluxation, we postulated that the thumb has an increased tendency to collapse in the palm (zigzag deformity). Therefore, LRTI after trapeziectomy could be a valuable treatment option in patients with stage IV OA. Several ligament reconstructions have been described using different tendon grafts. Some techniques use bone
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tunnels at the base of the first metacarpal whereas others avoid the use of such tunnels. Which kind of ligament reconstruction is superior is an ongoing debate. The drilling process to create a bone tunnel may be associated with severe complications, such as damage of the superficial radial nerve and fragmentation of the first metacarpal. So far, however, different LRTI procedures have not been compared in an RCT. Therefore, we conducted an RCT in women with stage IV OA at the base of the thumb, comparing the BurtonePellegrini (BP) and Weilby techniques. The BP technique is an LRTI arthroplasty with a bone tunnel at the base of the first metacarpal whereas the Weilby LRTI arthroplasty preserves the structural integrity of the first metacarpal base by not using a bone tunnel. We hypothesized that after the Weilby technique patients would show similar outcomes at 3 and 12 months’ follow-up with possibly fewer complications.
Burton-Pellegrini technique We made an incision along the radial border of the first metacarpal, after which we removed the trapezium. A tendon graft about 10 cm long and consisting of approximately one half of the flexor carpi ulnaris (FCR) tendon was dissected and tunneled to its insertion on the second metacarpal. This tendon graft was passed through a bone tunnel perpendicular to the thumbnail made with a 3.5-mm drill bit. The bone tunnel had an oblique orientation and the drill was passed from the radial cortex of the first metacarpal approximately 7 mm distal to the joint surface and dorsal of the abductor pollicis longus (APL) attachment exiting through the center of the joint surface. The graft was passed in the opposite direction and was fixed firmly to the periosteum and back onto itself beneath the APL attachment to resurface the base of the metacarpal. Its remaining length was sutured into a ball and secured in the trapezial space to act as a spacer, after which the joint capsule was closed. All sutures were performed with PDS 3-0 suture (Ethicon, Amersfoort, The Netherlands). The thumb was immobilized in a spica cast for 4 weeks, after which the cast was replaced by a removable protective orthosis and a hand therapist started standardized hand therapy focused on reducing edema and regaining functionality by increasing mobility, stability, and strength of the thumb.
PATIENTS AND METHODS Participants After we obtained approval from our institutional review board, we enrolled patients with symptomatic OA who failed to improve after nonsurgical treatment and who had stage IV OA of the thumb base5 in a single-center, single-blind, parallel-group RCT. An independent radiologist used 3 x-rays (posterioranterior, lateral, and Bett view) to determine the disease stage. To obtain a homogeneous group of primary OA patients, we only included women aged 40 years or older with unilateral or bilateral primary OA. This is a common strategy to increase the homogeneity of a study population.3 Patients with previous thumb surgery and patients with rheumatoid or posttraumatic OA were excluded. Patients were randomly allocated for treatment with either an LRTI based on the original reports of Burton and Pellegrini6 or an LRTI based on the original reports of Weilby.7,8
Weilby technique The trapezium was removed and the FCR tendon was harvested as described above. The tendon graft was then intertwined in a figure-of-8 fashion (at least twice) around the APL tendon and the rest of the FCR tendon, pulling those tendons together into the space created after trapeziectomy. The figure-of-8 configuration was locked by PDS 3-0 sutures. The remaining graft was sutured upon itself and was interposed in the trapezial void and pushed between the base of the first and second metacarpal. The Weilby group received the same immobilization period and standardized hand therapy as the BP group.
Randomization For equal distribution of patients between type of surgery and surgeon, software randomly assigned patient numbers to a treatment group and a surgeon using balanced block sizes of 20 patients. Sequentially numbered envelopes containing the assignment were used. After inclusion and informed consent, patients were assigned to the next envelope and therefore to a treatment group and a surgeon. Two European board-certified hand surgeons performed all surgeries. J Hand Surg Am.
Primary outcomes Our primary outcome measure for pain and physical function was the Patient-Rated Wrist/Hand Evaluation (PRWHE, Dutch language version) questionnaire (0 ¼ no pain and able to perform activities; 100 ¼ worst pain and unable to perform activities).9 The questionnaire has 2 subscores for pain and function and a total score. The PRWHE is a wrist- and hand-specific questionnaire with items about the affected wrist and hand alone. The more frequently used Disabilities of r
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the Arm, Shoulder, and Hand (DASH) questionnaire has an upper limbespecific character and is not specified for the affected hand. A report by MacDermid et al10 showed that the PRWHE questionnaire is more responsive in detecting clinical changes over time compared with the DASH. Patients were evaluated preoperatively and at 3 and 12 months after surgery.
TABLE 1.
Characteristics
BP Group
Patients, n
Dominance
Operated hand
36
36 63.5 8.5
Right
32
33
Left
2
2
Both
2
1
Right
15
17
Left
21
19
18 (50%)
18 (50%)
36
36
Dominant is operated hand (%) Classification
Weilby Group
64.7 9.1
Age, y (means SD)
Secondary outcomes For comparison with the literature, we also used the DASH questionnaire (Dutch language version) (0 ¼ no disability; 100 ¼ severe disability).11 Patients were evaluated at the same times the PRWHE was collected. At 12 months, we performed a patient global assessment by analyzing overall satisfaction (0 ¼ completely dissatisfied; 10 ¼ completely satisfied) and patients were asked whether they would have the same surgery again under similar circumstances. Furthermore, we registered how many weeks after surgery patients returned to work or normal daily life activities. All complications after surgery were registered for a period of 12 months and were divided into 3 categories: mild, moderate, and severe. Mild complications were those with minor clinical relevance, such as scar tenderness, temporary sensory disturbances, or infection. Moderate complications were clinically relevant and delayed patients’ recovery but did not need revision surgery and resolved 12 months after surgery. Examples are mild complex regional pain syndrome type I, tendinitis, and neuromas treated with steroid injections. Severe complications resulted in revision surgery, caused pain at rest, or impaired hand function at the 12-month examination. Examples are severe chronic regional pain syndrome type I, tendinitis, and neuromas that did not improve with steroids. In addition, we evaluated active range of motion (ROM) preoperatively and at 3 and 12 months for interphalangeal joint flexion-extension, metacarpophalangeal joint flexion-extension, and carpometacarpal (CMC) joint palmar abduction measured using the intermetacarpal distance. To calculate the intermetacarpal distance, the thumb was placed in full palmar abduction, the easily identifiable middorsal points on the subcutaneous surface of the first and second metacarpal heads were marked, and the separation between these was measured in millimeters.12 Furthermore, CMC joint opposition was measured using the Kapandji score (1e10: 1 ¼ the thumb reaches the lateral side of the second phalanx of the index finger; 10 ¼ the thumb reaches the distal volar J Hand Surg Am.
Baseline Characteristics in Both Groups
Stage IV
crease of the hand).13 We measured the tip pinch, key pinch, and 3-point pinch strengths using a baseline pinch gauge. Overall grip strength was measured using a baseline hydraulic hand dynamometer (Biometrics Ltd E-link H500 Hand Kit; Gwent, UK). The mean of 3 measurements was recorded as an outcome variable. All ROM and strength measurements were performed by independent hand therapists blinded to the study in accordance with a strict and previously published protocol.12,14 To calculate the degree of proximal migration of the first metacarpal, radiographic evaluation was performed at 12-month follow-up. For practical reasons and to reduce radiation exposure, we evaluated the first 20 consecutive patients. Standard Bett view radiographs were made with the hand at rest, with maximal pinch stress, and with the thumb tip opposed to the index finger. We measured the distance between the distal articular surface of the scaphoid and the proximal articular surface of the first metacarpal. The index of the height of the arthroplasty space was calculated by dividing the scaphoidemetacarpal distance by the length of the first metacarpal.15 We used the indices to compare the degree of proximal thumb migration between both groups at rest and during stress with the preoperative indices. Sample size We estimated that to achieve a power of 80%, approximately 45 patients per group were needed to detect a difference of 15 points (SD, 25) between both groups in the PRWHE questionnaire with a 2-sided 5% significance level. For this sample size estimation, we used a clinically relevant difference of 15 points r
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FIGURE 1: Flowchart of selection, inclusion, and dropouts of the study.
RESULTS A total of 79 consecutive patients were enrolled in this study conducted between 2008 and 2012. Table 1 presents baseline characteristics in both groups and Figure 1 shows the study flowchart. Because patients were randomized to type of surgery and surgeon, we performed a combined comparison of both groups as well as a separate analysis for both surgeons. Because both surgeons showed highly similar results, we choose to report only the difference between the 2 surgical procedures for both surgeons combined.
(SD, 25) based on a report by MacDermid and Tottenham.10 Statistical analysis We applied the intention-to-treat principle and used a generalized estimated equations approach to test the study hypothesis. Assuming that data were missing at random and not because of group allocation or treatment effect, this model estimates missing data values, thereby allowing the use of data from all participants. The interaction of group (Weilby vs BP) and time (baseline vs 3 months postoperative vs 12 months postoperative) was used to determine the efficacy of the intervention, because a significant interaction effect of group and time indicates that the change over time was significantly different between groups. The threshold for significance was set at .05. We used a Mann-Whitney test to compare overall patient satisfaction, the number of weeks before patients returned to work or normal daily life activities, and the proximal migration of the first metacarpal. All complications and the question of whether patients would have the same surgery under the same circumstances were analyzed with a chi-square test. J Hand Surg Am.
Pain and function Within-group comparisons of preoperative measurements at 3 and 12 months showed significant improvement in both groups for PRWHEepain (for all comparisons, P < .001), PRWHEeactivities (P < .001), PRWHEetotal (P < .001), and the DASH (P < .003). Between-group comparisons of the changes from preoperative values to 3 months after surgery showed a significantly larger improvement in the BP group for PRWHEepain and PRWHEetotal (Table 2), whereas PRWHEeactivities and the DASH score showed a trend toward significance at 3 months. Betweenegroup r
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TABLE 2.
Mean and Standard Error Scores on Clinical Outcome Measures and Their Changes Over Time
Questionnaires
Surgical Technique
Baseline
3 Mo
12 Mo
PRWHEepain (range, 0e50)
BP
36 1
18 2
18 3
Weilby
34 2
25 2
17 2
PRWHEeactivities (range, 0e50)
BP
35 1
20 3
15 3
Weilby
32 2
23 2
16 2
PRWHE total (range, 0e100)
BP
71 2
38 5
33 5
Weilby
67 3
48 4
33 5
DASH (range, 0e100)
BP
47 3
30 3
27 4
Weilby
46 2
37 3
30 3
BP
59 3
58 2
62 2
Weilby
58 2
57 2
59 2
Extension interphalangeal BP joint ( ) Weilby
e16 4
e11 3
e18 3
e19 3
e9 3
e12 4
BP
48 2
36 2
41 2
Weilby
47 2
36 2
38 2
e13 3
e15 3
e22 3
e7 3
e15 3
e22 2
P Value (D Short-Term)
P Value (D Long-Term)
.02
.73
.10
.23
.03
.39
.08
.45
.78
.61
.36
.12
.79
.66
.24
.23
.32
.60
.90
.59
.70
.001
.92
.37
.29
.78
.45
.36
.53
.99
Active ROM Flexion interphalangeal joint ( )
Flexion metacarpophalangeal joint ( ) Extension metacarpophalangeal joint ( )
BP Weilby
Palmar abduction (IMD), mm
BP
55 1
53 2
56 2
Weilby
54 1
55 1
57 1
Kapandji (range, 0e10)
BP
9 0.2
8 0.2
9 0.2
Weilby
9 0.3
8 0.3
9 0.2
Extension CMC joint, mm
BP
28 2
19 2
19 2
Weilby
23 2
15 2
24 2
BP
15 1
13 1
19 1
Weilby
15 1
13 1
18 1
BP
2.2 0.2
1.8 0.1
2.6 0.2
Weilby
2.3 0.2
2.3 0.2
2.7 0.2
BP
2.6 0.3
2.2 0.2
3.1 0.2
Weilby
2.9 0.3
2.3 0.2
3.2 0.2
BP
3.6 0.3
2.8 0.2
3.5 0.3
Weilby
3.6 0.3
3.0 0.3
3.5 0.5
Strength Grip strength, kg Tip pinch, kg 3-point pinch, Kg Key pinch, kg
P values of between-group comparisons of the change scores from baseline to 3 months (D short-term) and from baseline to 12 months (D long-term) are shown. IMD, intermetacarpal distance.
comparisons of the change scores from preoperative values to 12 months showed no significant difference in improvement between groups (Table 2).
was significantly different only for CMC extension at 12 months in favor of the Weilby group. All other active ROM measurements showed no significant differences between groups (Table 2).
Range of motion Between-group comparison of the changes in active ROM measurement scores from preoperative values to 3 months and from preoperative values to 12 months J Hand Surg Am.
Strength Between-group comparisons of the changes in scores in tip pinch, overall grip, 3-point pinch, and key pinch r
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Proximal migration Proximal migration in the BP group had a mean ratio of 0.21 (SD, 0.03) preoperatively, 0.11 (SD, 0.04) postoperatively without pinch stress, and 0.09 (SD, 0.05) postoperatively with maximal pinch stress. In the Weilby group, these values were 0.18 (SD, 0.07) preoperatively, 0.12 (SD, 0.06) postoperatively without pinch, and 0.06 (SD, 0.07) postoperatively with maximal pinch stress (no significant difference).
TABLE 3. Complications Recorded in Both Groups Surgical Technique BP
Weilby
Scar tenderness
2
0
Sensory changes
1
0
Infection
0
1
Tendinitis successfully treated with steroids
7
6
Neuroma successfully treated with steroids
1
0
Mild CRPS type I
0
2
Tendinitis requiring revision surgery
1
0
Neuroma requiring revision surgery
1
0
CRPS type I
0
0
13
9
Mild
Moderate
DISCUSSION The main findings of this study were that PRWHEe pain and PRWHEetotal scores were significantly more improved in the BP group compared with the Weilby group at the third-month interval and that PRWHEe activities and DASH score showed a trend toward significance at 3 months, also in favor of the BP group. Furthermore, the difference of 15 points on the PRWHEetotal score at 3 months in favor of the BP group was a clinically relevant difference.10,16 At 12 months we found no significant differences for all PRWHE and DASH scores between groups. These findings show that after the BP technique patients have better function and less pain 3 months after surgery, which indicates faster recovery in the BP group, whereas the outcome at 12 month was similar in both groups. In addition, we found 2 more moderate and severe complications in the BP group compared with the Weilby group; however, this difference was not statistically significant. Based on these results, we refuted our hypothesis that the Weilby technique shows similar outcomes with fewer complications compared with the BP technique. The finding that early recovery is better in the BP group is important. Although there are several small differences between the 2 surgical procedures, we believe that there are 2 important reasons for this finding. The first reason is a difference in suspension technique. The suspension method in the Weilby technique intertwines the FCR graft in a figure-of-8 fashion around the APL and the rest of the FCR, pulling those tendons together. We postulate that the active pulling forces of APL and FCR may result in an unphysiological tension that impairs function and increases pain in the early months after recovery. With the BP technique, the FCR graft is passed through a bone tunnel, which prevents tension on functional tendons. A second possible reason for the finding that early recovery was better in the BP group was the difference in interposition technique between the procedures. In the Weilby group the remaining graft was sutured upon itself and was pushed between the
Severe
Total, n
No significant differences existed in mild, moderate, and severe complications between groups. CRPS, complex regional pain syndrome.
strength from preoperative values to 3 months and from preoperative values to 12 months were not significantly different between groups (Table 2). Complications Between-group comparison indicated no significant differences between complications in both groups (P ¼ .84) (Table 3). Global assessment The mean overall satisfaction in BP group was 7.6 (SD, 2.7) compared with 7.1 (SD, 2.7) in the Weilby group (no significant difference, P ¼ .59). When we asked patients whether they would consider the same surgery again under the same circumstances, 68% in the BP group and 67% in the Weilby group responded with yes (P ¼ .93). Return to work or activities After the BP technique, patients returned to work after 9.5 weeks (SD, 5.6 wk), whereas patients with the Weilby technique returned 10.1 weeks (SD, 6.1 wk) after surgery, which was not significantly different (P ¼ .94). J Hand Surg Am.
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base of the first and second metacarpals, whereas in the BP group its remaining length was secured in the trapezial space. Analysis of active ROM measurements showed no significant differences between groups, except for significantly better CMC extension at 12 months in the Weilby group. We postulate, however, that the 5 mm better CMC extension in the Weilby group may be of minor clinical relevance because the PRWHE and DASH scores were not significantly different at 12 months. The time to return to work, overall satisfaction, and whether patients would consider the same surgery all were slightly in favor of the BP group, but none of these differences reached statistical significance. There were limitations to this study. An important one was that we could not include 45 patients in each group, which we needed based on our estimated sample size. We ended by including approximately 40 patients in each group. If more patients were included, some of the differences between groups that showed trends toward significance, such as the PRWHEeactivities and DASH score at 3 months, might have become statistically significant. Furthermore, we did not assess outcomes between 3 and 12 months, so we do not know when the results of the Weilby group equaled those of the BP group. In addition, we included a relatively homogeneous study group of only women with a severe type IV OA. As a result, our results should not be extrapolated to the male population or to less severe grades of OA. One retrospective comparative study17 compared 2 suspension techniques using APL slings, one with a suture anchor and another without. The study reported that suture anchor fixation was associated with pain and impaired postoperative function. The authors hypothesized that too-tight tendon fixation may be unphysiological and may cause pain and reduce strength. In our study, we also found that unphysiological tension on the APL and FCR tendon in the Weilby group resulted in impaired function and more pain early after the procedure. Because of the better early recovery, we prefer the BP technique over the Weilby technique in the treatment of stage IV OA.
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REFERENCES 1. Vermeulen GM, Slijper H, Feitz R, Hovius SE, Moojen TM, Selles RW. Surgical management of primary thumb carpometacarpal osteoarthritis: a systematic review. J Hand Surg Am. 2011;36(1): 157e169. 2. Wajon A, Carr E, Edmunds I, Ada L. Surgery for thumb (trapeziometacarpal joint) osteoarthritis. Cochrane Database Syst Rev. 2009;(4):CD004631. 3. Gangopadhyay S, McKenna H, Burke FD, Davis TR. Five- to 18year follow-up for treatment of trapeziometacarpal osteoarthritis: a prospective comparison of excision, tendon interposition, and ligament reconstruction and tendon interposition. J Hand Surg Am. 2012;37(3):411e417. 4. Salem H, Davis TR. Six year outcome excision of the trapezium for trapeziometacarpal joint osteoarthritis: is it improved by ligament reconstruction and temporary Kirschner wire insertion? J Hand Surg Eur Vol. 2012;37(3):211e219. 5. Eaton RG, Glickel SZ. Trapeziometacarpal osteoarthritis: staging as a rationale for treatment. Hand Clin. 1987;3(4):455e471. 6. Burton RI, Pellegrini VD Jr. Surgical management of basal joint arthritis of the thumb: Part II. Ligament reconstruction with tendon interposition arthroplasty. J Hand Surg Am. 1986;11(3):324e332. 7. Weilby A, Sondorf J. Results following removal of silicone trapezium metacarpal implants. J Hand Surg Am. 1978;3(2):154e156. 8. Weilby A. Tendon interposition arthroplasty of the first carpometacarpal joint. J Hand Surg Br. 1988;13(4):421e425. 9. Brink SM, Voskamp EG, Houpt P, Emmelot CH. Psychometric properties of the Patient Rated Wrist/Hand EvaluationeDutch Language Version (PRWH/E-DLV). J Hand Surg Eur Vol. 2009;34(4): 556e557. 10. MacDermid JC, Tottenham V. Responsiveness of the disability of the arm, shoulder, and hand (DASH) and patient-rated wrist/hand evaluation (PRWHE) in evaluating change after hand therapy. J Hand Ther. 2004;17(1):18e23. 11. Veehof MM, Sleegers EJ, van Veldhoven NH, Schuurman AH, van Meeteren NL. Psychometric qualities of the Dutch language version of the Disabilities of the Arm, Shoulder, and Hand questionnaire (DASH-DLV). J Hand Ther. 2002;15(4):347e354. 12. Murugkar PM, Brandsma JW, Anderson AM, Gurung K, Pun Y. Reliability of thumb web measurements. J Hand Ther. 2004;17(1): 58e63. 13. Kapandji A. Clinical test of apposition and counter-apposition of the thumb. Ann Chir Main. 1986;5(1):67e73. 14. Mathiowetz V, Kashman N, Volland G, Weber K, Dowe M, Rogers S. Grip and pinch strength: normative data for adults. Arch Phys Med Rehabil. 1985;66(2):69e74. 15. Yang SS, Weiland AJ. First metacarpal subsidence during pinch after ligament reconstruction and tendon interposition basal joint arthroplasty of the thumb. J Hand Surg Am. 1998;23(5):879e883. 16. Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013;38(4):641e649. 17. Nordback S, Erba P, Wehrli L, Raffoul W, Egloff DV. Trapeziectomy and tendon suspension with or without a mitek anchor fixation in the thumb basal joint osteoarthritis. J Hand Surg Eur Vol. 2012;37(7):625e631.
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Comparison of Arthroplasties With or Without Bone Tunnel Creation for Thumb Basal Joint Arthritis: A Randomized Controlled Trial Guus M. Vermeulen, MD, PhD, Kim R. Spekreijse, MD, Harm Slijper, PhD, Reinier Feitz, MD, Steven E. R. Hovius, MD, PhD, Ruud W. Selles, PhD
Purpose To compare the results for treatment of basal thumb osteoarthritis with and without the use of a bone tunnel at the base of the first metacarpal. Methods Women aged 40 years or older with stage IV osteoarthritis were randomized to 1 of 2 treatments. Patients were evaluated preoperatively and postoperatively at 3 and 12 months by assessing pain, outcome function measures, range of motion, strength, time to return to work or activities, satisfaction with the results, and complication rate. Results A total of 79 patients were enrolled in this study. Three months after surgery, PatientRated Wrist and Hand Evaluation pain and total scores were significantly improved in the bone tunnel group compared with the tunnel-free group. At 12 months, however, we found no significant differences for all outcome scores between groups. In addition, we observed no significant differences between groups in strength, duration to return to work or activities, patient satisfaction, and complication rates. Conclusions After the bone tunnel technique, patients have better function and less pain 3 months after surgery than do those in the nonebone tunnel group, which indicates faster recovery. However, 12 months after surgery, the functional outcome was similar. Because of faster recovery, we prefer the bone tunnel technique in the treatment of stage IV osteoarthritis. (J Hand Surg Am. 2014;:-e-. Copyright Ó 2014 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic I. Key words Ligament reconstruction, osteoarthritis, thumb, trapeziectomy, trapeziectomy with LRTI.
O
base of the thumb can result in major impairment.1,2 Two recent randomized controlled trials (RCT) found no benefit of ligament reconstruction and tendon STEOARTHRITIS (OA) AT THE
From the Department of Hand and Wrist Surgery, Diakonessenhuis Utrecht; the Department of Plastic Surgery and Hand Surgery, Erasmus MC University Medical Center, Rotterdam; the Department of Rehabilitation Medicine, Rotterdam; and the Xpert Clinic Hilversum, Hilversum, The Netherlands. Received for publication December 22, 2013; accepted in revised form April 23, 2014. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Corresponding author: Guus M. Vermeulen, MD, PhD, Department of Hand and Wrist Surgery, Xpert Clinic Hilversum, Loosdrechtse Bos 15, 1213 RH Hilversum, The Netherlands; e-mail: [email protected]. 0363-5023/14/---0001$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2014.04.044
interposition (LRTI) after trapeziectomy in the long term (> 5 y) compared with trapeziectomy alone.3,4 However, because only 10% of patients in those studies had scaphotrapeziotrapezoid joint OA (stage IV OA according to the radiographic criteria of Eaton and Glickel5), these results primarily apply to stage II and III OA (radiographic OA only at the trapeziometacarpal joint). Because stage IV OA is characterized by more cartilage and ligament damage and metacarpal subluxation, we postulated that the thumb has an increased tendency to collapse in the palm (zigzag deformity). Therefore, LRTI after trapeziectomy could be a valuable treatment option in patients with stage IV OA. Several ligament reconstructions have been described using different tendon grafts. Some techniques use bone
Ó 2014 ASSH
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RCT: LRTI WITH OR WITHOUT BONE TUNNEL CREATION IN THUMB BASE OSTEOARTHRITIS
tunnels at the base of the first metacarpal whereas others avoid the use of such tunnels. Which kind of ligament reconstruction is superior is an ongoing debate. The drilling process to create a bone tunnel may be associated with severe complications, such as damage of the superficial radial nerve and fragmentation of the first metacarpal. So far, however, different LRTI procedures have not been compared in an RCT. Therefore, we conducted an RCT in women with stage IV OA at the base of the thumb, comparing the BurtonePellegrini (BP) and Weilby techniques. The BP technique is an LRTI arthroplasty with a bone tunnel at the base of the first metacarpal whereas the Weilby LRTI arthroplasty preserves the structural integrity of the first metacarpal base by not using a bone tunnel. We hypothesized that after the Weilby technique patients would show similar outcomes at 3 and 12 months’ follow-up with possibly fewer complications.
Burton-Pellegrini technique We made an incision along the radial border of the first metacarpal, after which we removed the trapezium. A tendon graft about 10 cm long and consisting of approximately one half of the flexor carpi ulnaris (FCR) tendon was dissected and tunneled to its insertion on the second metacarpal. This tendon graft was passed through a bone tunnel perpendicular to the thumbnail made with a 3.5-mm drill bit. The bone tunnel had an oblique orientation and the drill was passed from the radial cortex of the first metacarpal approximately 7 mm distal to the joint surface and dorsal of the abductor pollicis longus (APL) attachment exiting through the center of the joint surface. The graft was passed in the opposite direction and was fixed firmly to the periosteum and back onto itself beneath the APL attachment to resurface the base of the metacarpal. Its remaining length was sutured into a ball and secured in the trapezial space to act as a spacer, after which the joint capsule was closed. All sutures were performed with PDS 3-0 suture (Ethicon, Amersfoort, The Netherlands). The thumb was immobilized in a spica cast for 4 weeks, after which the cast was replaced by a removable protective orthosis and a hand therapist started standardized hand therapy focused on reducing edema and regaining functionality by increasing mobility, stability, and strength of the thumb.
PATIENTS AND METHODS Participants After we obtained approval from our institutional review board, we enrolled patients with symptomatic OA who failed to improve after nonsurgical treatment and who had stage IV OA of the thumb base5 in a single-center, single-blind, parallel-group RCT. An independent radiologist used 3 x-rays (posterioranterior, lateral, and Bett view) to determine the disease stage. To obtain a homogeneous group of primary OA patients, we only included women aged 40 years or older with unilateral or bilateral primary OA. This is a common strategy to increase the homogeneity of a study population.3 Patients with previous thumb surgery and patients with rheumatoid or posttraumatic OA were excluded. Patients were randomly allocated for treatment with either an LRTI based on the original reports of Burton and Pellegrini6 or an LRTI based on the original reports of Weilby.7,8
Weilby technique The trapezium was removed and the FCR tendon was harvested as described above. The tendon graft was then intertwined in a figure-of-8 fashion (at least twice) around the APL tendon and the rest of the FCR tendon, pulling those tendons together into the space created after trapeziectomy. The figure-of-8 configuration was locked by PDS 3-0 sutures. The remaining graft was sutured upon itself and was interposed in the trapezial void and pushed between the base of the first and second metacarpal. The Weilby group received the same immobilization period and standardized hand therapy as the BP group.
Randomization For equal distribution of patients between type of surgery and surgeon, software randomly assigned patient numbers to a treatment group and a surgeon using balanced block sizes of 20 patients. Sequentially numbered envelopes containing the assignment were used. After inclusion and informed consent, patients were assigned to the next envelope and therefore to a treatment group and a surgeon. Two European board-certified hand surgeons performed all surgeries. J Hand Surg Am.
Primary outcomes Our primary outcome measure for pain and physical function was the Patient-Rated Wrist/Hand Evaluation (PRWHE, Dutch language version) questionnaire (0 ¼ no pain and able to perform activities; 100 ¼ worst pain and unable to perform activities).9 The questionnaire has 2 subscores for pain and function and a total score. The PRWHE is a wrist- and hand-specific questionnaire with items about the affected wrist and hand alone. The more frequently used Disabilities of r
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RCT: LRTI WITH OR WITHOUT BONE TUNNEL CREATION IN THUMB BASE OSTEOARTHRITIS
the Arm, Shoulder, and Hand (DASH) questionnaire has an upper limbespecific character and is not specified for the affected hand. A report by MacDermid et al10 showed that the PRWHE questionnaire is more responsive in detecting clinical changes over time compared with the DASH. Patients were evaluated preoperatively and at 3 and 12 months after surgery.
TABLE 1.
Characteristics
BP Group
Patients, n
Dominance
Operated hand
36
36 63.5 8.5
Right
32
33
Left
2
2
Both
2
1
Right
15
17
Left
21
19
18 (50%)
18 (50%)
36
36
Dominant is operated hand (%) Classification
Weilby Group
64.7 9.1
Age, y (means SD)
Secondary outcomes For comparison with the literature, we also used the DASH questionnaire (Dutch language version) (0 ¼ no disability; 100 ¼ severe disability).11 Patients were evaluated at the same times the PRWHE was collected. At 12 months, we performed a patient global assessment by analyzing overall satisfaction (0 ¼ completely dissatisfied; 10 ¼ completely satisfied) and patients were asked whether they would have the same surgery again under similar circumstances. Furthermore, we registered how many weeks after surgery patients returned to work or normal daily life activities. All complications after surgery were registered for a period of 12 months and were divided into 3 categories: mild, moderate, and severe. Mild complications were those with minor clinical relevance, such as scar tenderness, temporary sensory disturbances, or infection. Moderate complications were clinically relevant and delayed patients’ recovery but did not need revision surgery and resolved 12 months after surgery. Examples are mild complex regional pain syndrome type I, tendinitis, and neuromas treated with steroid injections. Severe complications resulted in revision surgery, caused pain at rest, or impaired hand function at the 12-month examination. Examples are severe chronic regional pain syndrome type I, tendinitis, and neuromas that did not improve with steroids. In addition, we evaluated active range of motion (ROM) preoperatively and at 3 and 12 months for interphalangeal joint flexion-extension, metacarpophalangeal joint flexion-extension, and carpometacarpal (CMC) joint palmar abduction measured using the intermetacarpal distance. To calculate the intermetacarpal distance, the thumb was placed in full palmar abduction, the easily identifiable middorsal points on the subcutaneous surface of the first and second metacarpal heads were marked, and the separation between these was measured in millimeters.12 Furthermore, CMC joint opposition was measured using the Kapandji score (1e10: 1 ¼ the thumb reaches the lateral side of the second phalanx of the index finger; 10 ¼ the thumb reaches the distal volar J Hand Surg Am.
Baseline Characteristics in Both Groups
Stage IV
crease of the hand).13 We measured the tip pinch, key pinch, and 3-point pinch strengths using a baseline pinch gauge. Overall grip strength was measured using a baseline hydraulic hand dynamometer (Biometrics Ltd E-link H500 Hand Kit; Gwent, UK). The mean of 3 measurements was recorded as an outcome variable. All ROM and strength measurements were performed by independent hand therapists blinded to the study in accordance with a strict and previously published protocol.12,14 To calculate the degree of proximal migration of the first metacarpal, radiographic evaluation was performed at 12-month follow-up. For practical reasons and to reduce radiation exposure, we evaluated the first 20 consecutive patients. Standard Bett view radiographs were made with the hand at rest, with maximal pinch stress, and with the thumb tip opposed to the index finger. We measured the distance between the distal articular surface of the scaphoid and the proximal articular surface of the first metacarpal. The index of the height of the arthroplasty space was calculated by dividing the scaphoidemetacarpal distance by the length of the first metacarpal.15 We used the indices to compare the degree of proximal thumb migration between both groups at rest and during stress with the preoperative indices. Sample size We estimated that to achieve a power of 80%, approximately 45 patients per group were needed to detect a difference of 15 points (SD, 25) between both groups in the PRWHE questionnaire with a 2-sided 5% significance level. For this sample size estimation, we used a clinically relevant difference of 15 points r
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RCT: LRTI WITH OR WITHOUT BONE TUNNEL CREATION IN THUMB BASE OSTEOARTHRITIS
FIGURE 1: Flowchart of selection, inclusion, and dropouts of the study.
RESULTS A total of 79 consecutive patients were enrolled in this study conducted between 2008 and 2012. Table 1 presents baseline characteristics in both groups and Figure 1 shows the study flowchart. Because patients were randomized to type of surgery and surgeon, we performed a combined comparison of both groups as well as a separate analysis for both surgeons. Because both surgeons showed highly similar results, we choose to report only the difference between the 2 surgical procedures for both surgeons combined.
(SD, 25) based on a report by MacDermid and Tottenham.10 Statistical analysis We applied the intention-to-treat principle and used a generalized estimated equations approach to test the study hypothesis. Assuming that data were missing at random and not because of group allocation or treatment effect, this model estimates missing data values, thereby allowing the use of data from all participants. The interaction of group (Weilby vs BP) and time (baseline vs 3 months postoperative vs 12 months postoperative) was used to determine the efficacy of the intervention, because a significant interaction effect of group and time indicates that the change over time was significantly different between groups. The threshold for significance was set at .05. We used a Mann-Whitney test to compare overall patient satisfaction, the number of weeks before patients returned to work or normal daily life activities, and the proximal migration of the first metacarpal. All complications and the question of whether patients would have the same surgery under the same circumstances were analyzed with a chi-square test. J Hand Surg Am.
Pain and function Within-group comparisons of preoperative measurements at 3 and 12 months showed significant improvement in both groups for PRWHEepain (for all comparisons, P < .001), PRWHEeactivities (P < .001), PRWHEetotal (P < .001), and the DASH (P < .003). Between-group comparisons of the changes from preoperative values to 3 months after surgery showed a significantly larger improvement in the BP group for PRWHEepain and PRWHEetotal (Table 2), whereas PRWHEeactivities and the DASH score showed a trend toward significance at 3 months. Betweenegroup r
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TABLE 2.
Mean and Standard Error Scores on Clinical Outcome Measures and Their Changes Over Time
Questionnaires
Surgical Technique
Baseline
3 Mo
12 Mo
PRWHEepain (range, 0e50)
BP
36 1
18 2
18 3
Weilby
34 2
25 2
17 2
PRWHEeactivities (range, 0e50)
BP
35 1
20 3
15 3
Weilby
32 2
23 2
16 2
PRWHE total (range, 0e100)
BP
71 2
38 5
33 5
Weilby
67 3
48 4
33 5
DASH (range, 0e100)
BP
47 3
30 3
27 4
Weilby
46 2
37 3
30 3
BP
59 3
58 2
62 2
Weilby
58 2
57 2
59 2
Extension interphalangeal BP joint ( ) Weilby
e16 4
e11 3
e18 3
e19 3
e9 3
e12 4
BP
48 2
36 2
41 2
Weilby
47 2
36 2
38 2
e13 3
e15 3
e22 3
e7 3
e15 3
e22 2
P Value (D Short-Term)
P Value (D Long-Term)
.02
.73
.10
.23
.03
.39
.08
.45
.78
.61
.36
.12
.79
.66
.24
.23
.32
.60
.90
.59
.70
.001
.92
.37
.29
.78
.45
.36
.53
.99
Active ROM Flexion interphalangeal joint ( )
Flexion metacarpophalangeal joint ( ) Extension metacarpophalangeal joint ( )
BP Weilby
Palmar abduction (IMD), mm
BP
55 1
53 2
56 2
Weilby
54 1
55 1
57 1
Kapandji (range, 0e10)
BP
9 0.2
8 0.2
9 0.2
Weilby
9 0.3
8 0.3
9 0.2
Extension CMC joint, mm
BP
28 2
19 2
19 2
Weilby
23 2
15 2
24 2
BP
15 1
13 1
19 1
Weilby
15 1
13 1
18 1
BP
2.2 0.2
1.8 0.1
2.6 0.2
Weilby
2.3 0.2
2.3 0.2
2.7 0.2
BP
2.6 0.3
2.2 0.2
3.1 0.2
Weilby
2.9 0.3
2.3 0.2
3.2 0.2
BP
3.6 0.3
2.8 0.2
3.5 0.3
Weilby
3.6 0.3
3.0 0.3
3.5 0.5
Strength Grip strength, kg Tip pinch, kg 3-point pinch, Kg Key pinch, kg
P values of between-group comparisons of the change scores from baseline to 3 months (D short-term) and from baseline to 12 months (D long-term) are shown. IMD, intermetacarpal distance.
comparisons of the change scores from preoperative values to 12 months showed no significant difference in improvement between groups (Table 2).
was significantly different only for CMC extension at 12 months in favor of the Weilby group. All other active ROM measurements showed no significant differences between groups (Table 2).
Range of motion Between-group comparison of the changes in active ROM measurement scores from preoperative values to 3 months and from preoperative values to 12 months J Hand Surg Am.
Strength Between-group comparisons of the changes in scores in tip pinch, overall grip, 3-point pinch, and key pinch r
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RCT: LRTI WITH OR WITHOUT BONE TUNNEL CREATION IN THUMB BASE OSTEOARTHRITIS
Proximal migration Proximal migration in the BP group had a mean ratio of 0.21 (SD, 0.03) preoperatively, 0.11 (SD, 0.04) postoperatively without pinch stress, and 0.09 (SD, 0.05) postoperatively with maximal pinch stress. In the Weilby group, these values were 0.18 (SD, 0.07) preoperatively, 0.12 (SD, 0.06) postoperatively without pinch, and 0.06 (SD, 0.07) postoperatively with maximal pinch stress (no significant difference).
TABLE 3. Complications Recorded in Both Groups Surgical Technique BP
Weilby
Scar tenderness
2
0
Sensory changes
1
0
Infection
0
1
Tendinitis successfully treated with steroids
7
6
Neuroma successfully treated with steroids
1
0
Mild CRPS type I
0
2
Tendinitis requiring revision surgery
1
0
Neuroma requiring revision surgery
1
0
CRPS type I
0
0
13
9
Mild
Moderate
DISCUSSION The main findings of this study were that PRWHEe pain and PRWHEetotal scores were significantly more improved in the BP group compared with the Weilby group at the third-month interval and that PRWHEe activities and DASH score showed a trend toward significance at 3 months, also in favor of the BP group. Furthermore, the difference of 15 points on the PRWHEetotal score at 3 months in favor of the BP group was a clinically relevant difference.10,16 At 12 months we found no significant differences for all PRWHE and DASH scores between groups. These findings show that after the BP technique patients have better function and less pain 3 months after surgery, which indicates faster recovery in the BP group, whereas the outcome at 12 month was similar in both groups. In addition, we found 2 more moderate and severe complications in the BP group compared with the Weilby group; however, this difference was not statistically significant. Based on these results, we refuted our hypothesis that the Weilby technique shows similar outcomes with fewer complications compared with the BP technique. The finding that early recovery is better in the BP group is important. Although there are several small differences between the 2 surgical procedures, we believe that there are 2 important reasons for this finding. The first reason is a difference in suspension technique. The suspension method in the Weilby technique intertwines the FCR graft in a figure-of-8 fashion around the APL and the rest of the FCR, pulling those tendons together. We postulate that the active pulling forces of APL and FCR may result in an unphysiological tension that impairs function and increases pain in the early months after recovery. With the BP technique, the FCR graft is passed through a bone tunnel, which prevents tension on functional tendons. A second possible reason for the finding that early recovery was better in the BP group was the difference in interposition technique between the procedures. In the Weilby group the remaining graft was sutured upon itself and was pushed between the
Severe
Total, n
No significant differences existed in mild, moderate, and severe complications between groups. CRPS, complex regional pain syndrome.
strength from preoperative values to 3 months and from preoperative values to 12 months were not significantly different between groups (Table 2). Complications Between-group comparison indicated no significant differences between complications in both groups (P ¼ .84) (Table 3). Global assessment The mean overall satisfaction in BP group was 7.6 (SD, 2.7) compared with 7.1 (SD, 2.7) in the Weilby group (no significant difference, P ¼ .59). When we asked patients whether they would consider the same surgery again under the same circumstances, 68% in the BP group and 67% in the Weilby group responded with yes (P ¼ .93). Return to work or activities After the BP technique, patients returned to work after 9.5 weeks (SD, 5.6 wk), whereas patients with the Weilby technique returned 10.1 weeks (SD, 6.1 wk) after surgery, which was not significantly different (P ¼ .94). J Hand Surg Am.
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RCT: LRTI WITH OR WITHOUT BONE TUNNEL CREATION IN THUMB BASE OSTEOARTHRITIS
base of the first and second metacarpals, whereas in the BP group its remaining length was secured in the trapezial space. Analysis of active ROM measurements showed no significant differences between groups, except for significantly better CMC extension at 12 months in the Weilby group. We postulate, however, that the 5 mm better CMC extension in the Weilby group may be of minor clinical relevance because the PRWHE and DASH scores were not significantly different at 12 months. The time to return to work, overall satisfaction, and whether patients would consider the same surgery all were slightly in favor of the BP group, but none of these differences reached statistical significance. There were limitations to this study. An important one was that we could not include 45 patients in each group, which we needed based on our estimated sample size. We ended by including approximately 40 patients in each group. If more patients were included, some of the differences between groups that showed trends toward significance, such as the PRWHEeactivities and DASH score at 3 months, might have become statistically significant. Furthermore, we did not assess outcomes between 3 and 12 months, so we do not know when the results of the Weilby group equaled those of the BP group. In addition, we included a relatively homogeneous study group of only women with a severe type IV OA. As a result, our results should not be extrapolated to the male population or to less severe grades of OA. One retrospective comparative study17 compared 2 suspension techniques using APL slings, one with a suture anchor and another without. The study reported that suture anchor fixation was associated with pain and impaired postoperative function. The authors hypothesized that too-tight tendon fixation may be unphysiological and may cause pain and reduce strength. In our study, we also found that unphysiological tension on the APL and FCR tendon in the Weilby group resulted in impaired function and more pain early after the procedure. Because of the better early recovery, we prefer the BP technique over the Weilby technique in the treatment of stage IV OA.
J Hand Surg Am.
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