CLINICAL ARTICLE

Prospective, Randomized Evaluation of Endoscopic Versus Open Carpal Tunnel Release in Bilateral Carpal Tunnel Syndrome An Interim Analysis Brett Michelotti, MD, Diane Romanowsky, PA-C, and Randy M. Hauck, MD Background: Most randomized trials have shown similar results with endoscopic carpal tunnel release (ECTR) and open carpal tunnel release (OCTR); however, there are studies suggesting less postoperative pain, faster improvement in grip and pinch strength, and earlier return to work with the endoscopic technique. The goal of this study was to prospectively examine subjective and functional outcomes, satisfaction, and complications after both ECTR and OCTR in the opposite hands of the same patient, serving as their own control. Methods: This was a prospective, randomized study in which patients underwent surgery for bilateral carpal tunnel syndrome. The first carpal tunnel release was performed on the most symptomatic handVdetermined by the patient. Operative approach was randomly assigned and, approximately 1 month later, the alternative technique was performed on the contralateral side. Demographic data were obtained, and functional outcomes were recorded preoperatively and postoperatively, including pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength, and overall grip strength. The carpal tunnel syndrome-functional status score and carpal tunnel syndrome-symptom severity score were recorded before surgery and at 2, 4, 8, 12, and 24 weeks postoperatively. Overall satisfaction with each technique was recorded at the conclusion of the study. Results: Currently, 25 subjects have completed final visit testing. There were no differences in pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength, or overall grip strength at any of the postoperative time points. Carpal tunnel syndrome-symptom severity score and carpal tunnel syndrome-functional status score were not significantly different between groups at any of the evaluations. Overall satisfaction, where patients recorded a number from 0 to 100, was significantly greater in the ECTR group (95.95 vs 91.60, P = 0.04). There were no complications with either technique. Discussion: This interim analysis, using the same patient as an internal control, suggests that both OCTR and ECTR are well tolerated with no differences in functional outcomes, symptom severity and functional status questionnaires, or complications. Although there were no differences between groups using our study metrics, patients still preferred the ECTR, demonstrated by significantly higher overall satisfaction scores at the conclusion of the study. Key Words: carpal tunnel syndrome, carpal tunnel release, endoscopic, prospective, randomized trial (Ann Plast Surg 2014;73: S157YS160)

become the most common hand operation in the United States.1 Recent data have indicated that the incidence of carpal tunnel syndrome may be increasing because of increasing life expectancy with a subsequent rise in number of operations in our aging population.2 Release of the transverse carpal ligament can be performed by several different approachesVall of which are modifications of the traditional open technique and the newer endoscopic techniques. The endoscopic technique used in this study was originally designed and described by Agee et al3Y5 (Fig. 1). This operative technique involves insertion of the operating device through a single-port, 1.5-cm horizontal incision at the middistal wrist crease, ulnar to the palmaris longus if present, where the transverse carpal ligament is transected from distal to proximal. In the original randomized controlled trial performed by Agee and colleagues comparing the endoscopic [endoscopic carpal tunnel release (ECTR)] and open techniques [open carpal tunnel release (OCTR)], patients had earlier return to workVwhen adjusted for worker’s compensationVless postoperative pain, and earlier return to preoperative levels of activities of daily living.3 There exists significant heterogeneity in randomized, controlled trials that have been performed in the last 2 decades. A recent metaanalysis of randomized, controlled trials suggested that the endoscopic technique was favored over the open technique with respect to scar tenderness at 12-week follow-up, grip and pinch strength. There were no differences in symptom relief or return to work. Similar to prior studies, this meta-analysis determined that there was a higher incidence of reversible median nerve injury in the endoscopic carpal tunnel decompression group as compared to the open group.6 In a meta-analysis of randomized, controlled trials performed by Sanati et al7 specifically looking at return to work, authors concluded that a minimally invasive approach results in earlier return to work as compared to the open approach (4.4 vs 7.2 days); however, authors criticized the descriptions of how patients were counseled on return to work and noted that reporting of actual return to work was inconsistent across studies. The goal of this study was to prospectively examine postoperative patient satisfaction, functional outcomes, and complications after both ECTR and OCTR in the opposite hands of the same patient, serving as their own internal control.

BACKGROUND Median nerve compression within the carpal tunnel results in the most prevalent nerve compression syndrome and carpal tunnel release has Received February 10, 2014, and accepted for publication, after revision, February 14, 2014. From the Division of Plastic Surgery, Department of Surgery, Milton S. Hershey Medical Center, College of Medicine, Pennsylvania State University, Hershey, PA. Conflicts of interest and sources of funding: none declared. Reprints: Brett Michelotti, MD, Division of Plastic Surgery, College of Medicine, Pennsylvania State University, H071, 500 University Dr, Hershey, PA 17033. E-mail: [email protected] Copyright * 2014 by Lippincott Williams & Wilkins ISSN: 0148-7043/14/7302-S157 DOI: 10.1097/SAP.0000000000000203

Annals of Plastic Surgery

METHODS This was an institutional review boardYapproved, prospective, randomized study in which patients underwent surgery for bilateral carpal tunnel syndrome. Patients were recruited from the senior author’s practice at the Penn State Hershey Medical Center-Bone and Joint Institute. Inclusion criteria were age 18 to 75 years, clinical diagnosis of bilateral, primary carpal tunnel syndrome, electrodiagnostic confirmation of bilateral carpal tunnel syndrome, and failed nonsurgical management (ie, splint, corticosteroid injection). Exclusion criteria were recurrent carpal tunnel syndrome, inflammatory arthropathy, peripheral neuropathy, younger than 18 or older than 75 years, or pregnancy at the time of enrollment.

& Volume 73, Supplement 2, December 2014

www.annalsplasticsurgery.com

Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

S157

Annals of Plastic Surgery

Michelotti et al

& Volume 73, Supplement 2, December 2014

randomization schedule was used to determine which procedure would be performed (open or endoscopic.) Patients knew which surgery was to be performed on the day of surgery, before the operation. Independent samples t tests were conducted between the ECTR and OCTR procedures on the primary and secondary outcomes. Complication rates were recorded after review of the postoperative medical record.

RESULTS

FIGURE 1. Single-portal ECTR.

The first carpal tunnel release was performed on the most symptomatic handVas determined by the patient. Initial operative approach (OCTR vs ECTR) was randomly assigned and then, at least 1 month later, the alternative technique was performed on the contralateral hand. All of the surgeries were performed on an outpatient basis where patients were discharged the day of surgery. The anesthesia provided was consistent for both groups where patients received local anesthesia and intravenous sedation using a combination of benzodiazepines and propofol. Demographic data were collected after obtaining written informed consent to participate in the study. Variable of interest included age, sex, hand dominance, duration of symptoms, occupation, previous treatment with splint and/or corticosteroids (including duration of treatment), workman’s compensation claim (yes/no), and medical comorbid conditions. All women of child-bearing age underwent pregnancy tests at the time of surgery. Preoperative clinical assessment of symptoms was documented including electromyography for both electrodiagnostic confirmation and quantitative analysis. Functional outcomes were recorded at the time of study enrollment and at 2, 4, 8, 12, and 24 weeks postoperatively. These data included pain, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength, and overall grip strength. The carpal tunnel syndrome-functional status score (CTS-FSS) and carpal tunnel syndrome-symptom severity score (CTS-SSS) were also documented before and after surgery. Overall satisfaction with each technique, where patients recorded a number from 0% to 100%, was recorded at the conclusion of the study. Patients were asked to comment on why they preferred one technique over the other. The endoscopic technique performed by the senior author, originally described by Agee et al, uses a single-port, 1.5-cm horizontal incision at the middistal wrist crease, ulnar to the palmaris longus if present, with insertion of the endoscopic device within the carpal tunnel, radial to the hook of the hamate, where the transverse carpal ligament is transected from distal to proximal. The antebrachial fascia is also released several centimeters proximal to the palmar incision. The open technique is performed by releasing the transverse carpal ligament along the ring finger ray from distal to proximal but ceasing approximately 5 mm from the distal wrist crease. The primary outcome measures in this study were the CTSFSS and CTS-SSS. Functional outcomes, complication rates, and patient satisfaction were analyzed as secondary outcomes. To detect a clinically significant difference of 0.5 in CTS-FSS and CTS-SSS scoring between groups, we aim to recruit 59 patients to achieve a 5% significance level and 90% power. Assuming an approximately 15% dropout rate, we will need to recruit 68 total patients to achieve statistical power. At the time of this preliminary analysis, 25 have been recruited and have completed final visit testing, therefore, were included in statistical analysis. After the patient decided on which hand he/she wanted the first surgeryVwhichever was more symptomaticVa computer-generated S158

www.annalsplasticsurgery.com

With this interim analysis, 25 subjects have completed their final visit testing and were included in the statistical analysis. The average age in our cohort was 53 years, where female retirees or housewives comprised the largest portion of our cohort (32%) (Table 1). Right-handedness predominated comprising 92% of the cohort. Patients randomized to receive the ECTR as the first operation had a mean preoperative CTS-FSS of 2.27 (E-Ave) and those who underwent open release had a mean preoperative CTS-FSS of 2.18 (O-Ave). There was no difference between groups. At the conclusion of the study, CTS-FSS values improved in both groups: 1.13-ECTR and 1.14-OCTR. There was no difference in improvement between groups at the conclusion of the study or at any of the postoperative evaluations (Table 2). Similarly, there was no difference in preoperative CTS-SSS between groups nor was there a difference in improvement in CTS-SSS at any of the postoperative time points, although patients did report better scores after either operation. Preoperative average CTS-SSS for the endoscopic group was 2.66 and the average preoperative score for the OCTR group was 2.50, with final visit values of 1.21 and 1.19, respectively (Table 3). Patients noted very little pain with either operation reaching a height of approximately 2 of 10 pain at the 2-week postoperative visit TABLE 1. Patient Demographics Age, y

Sex

Occupation

Endo Side

63 27 43 59 60 57 51 63 63 51 46 55 57 70 53 36 33 46 51 36 53 55 75 57 63

F F F M F F F F F F F M F F F F F F F F F M M F F

Office worker CAN Medical assistant Disabled-back problems Housewife Phlebotomist RN-administration Data analyst Disabled-MVA Clerical Housewife Retired Teacher Hairstylist Homemaker Dues processor Radiology technician Accountant Laboratory technician Human resources MH houseparent Truck driver Retired Retired Retired

R L R L L L R L L L R R R R L L L L R L R R R R L

Dominant Hand R R R R R R R L L/R R R R R R R R R R R R R R L R R

* 2014 Lippincott Williams & Wilkins

Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Annals of Plastic Surgery

& Volume 73, Supplement 2, December 2014

TABLE 2. Carpal Tunnel Syndrome-Functional Status Score O-Ave E-Ave P

Preoperative

2 wk

4 wk

8 wk

12 wk

24 wk

2.18 2.27 0.68

1.91 1.74 0.14

1.47 1.39 0.24

1.29 1.25 0.33

1.23 1.18 0.29

1.14 1.13 0.92

ECTR vs OCTR in Bilateral Carpal Tunnel Syndrome

TABLE 4. Pain Score (Visual Analog Score) O-Ave E-Ave P

Preoperative

2 wk

4 wk

8 wk

12 wk

24 wk

1.06 1.33 0.65

1.63 1.58 0.47

1.07 0.92 0.37

0.50 0.86 0.23

0.40 0.26 0.29

0.23 0.19 0.44

We present the interim analysis of a single-surgeon, randomized trial comparing ECTR to OCTR in bilateral carpal tunnel

syndrome where patients serve as their own internal control. The senior author has extensive experience performing single-port endoscopic carpal tunnel decompression and therefore we reduce the bias that prior studies have incurred where authors had reportedly learned the endoscopic technique for the purposes of the study and were theoretically more prone to error, adverse events, and incomplete release or failure to observe improvement in symptom relief. An additional strength of this study is our ability to perform the alternative carpal tunnel decompression technique on the opposite hand of the same patientVserving as their own internal control. This reduces bias associated with reporting of subjective patient variables, particularly pain, CTS-SSS, and CTS-FSS. Patients were randomized to receive either the ECTR or OCTR based on a preoperative blockrandomization schedule controlling for hand-dominance. Therefore, an equal number of patients first received the endoscopic technique as compared to those who underwent the open technique as their first operation. An important variable to consider when comparing open to endoscopic carpal tunnel decompression is return to workValthough this outcome as a study variable continues to be a contentious point within the literature. Some argue that return to work is more dependent on intrinsic patient characteristics, potential gain by the patient (disability, worker’s compensation, etc), or surgeon determination of an appropriate timeline for return than of the surgery itself. A recent study by Cowan et al followed a cohort of 56 employed patients who underwent limited incision carpal tunnel release in an attempt to identify determinants of patient return to work. The authors determined that job type was the most important predictor of return to work (those with desk jobs returned more quickly than manual laborers) but also identified psychological factors that influenced return to work including preoperative patient expectations, anxiety in response to pain, and catastrophic thinking.8 In the meta-analysis written by Thoma et al,6 the authors found no difference in return to work between the randomized studies that were analyzed. Of the 5 studies, 3 revealed no difference in return to work between groups, 1 favored the endoscopic group (oneport endoscopic technique), and 1 favored the OCTR group (2-port endoscopic technique).9,10 Due to the design of our study in which patients underwent surgery on both hands in the setting of bilateral carpal tunnel syndrome, we were unable to evaluate return to work. Patients underwent the second operation at least 1 month after the first operation and most of our patients were retirees or housewives. In the meta-analysis of randomized trials by Thoma et al, the authors determined that improvements in grip strength and key-pinch strength at short-term follow-up favor the endoscopic decompression group. When analyzed as a grouped cohort, reversible nerve damage was documented more frequently in the endoscopic decompression groupValthough the studies in question are heterogeneous in terms of surgical technique and surgeon familiarity with the operation.6 With this interim analysis, we have found no differences in functional

TABLE 3. Carpal Tunnel Syndrome-Symptom Severity Score

TABLE 5. Two-Point Discrimination

in both groups and all patients were essentially pain free at the time of the interim analysis (Table 4). As a trend, 2-point discrimination improved in both groups with preoperative values greater than 6 mm and final visit values of approximately 5 mm, although there was no difference in improvement between groups (Table 5). Preoperative Semmes-Weinstein monofilament testing was performed on all digits in each of the subjects. Only the thumb values were compared with this statistical analysis. Preoperative values did not differ between groups where the average SW measurement in the ECTR group was 3.64 and 3.78 in the OCTR group. Monofilament testing improved slightly in both groups but did not differ statistically. All but 2 patients demonstrated improvements in sensibility by SW measurements. These 2 patients had excellent sensibility preoperatively and this value (2.83) did not improve after surgery (Table 6). Average preoperative abductor pollicis brevis (APB) strength in the ECTR group was 4.50 versus 4.52 in the open decompression group. Average APB strength improved in both groups, with final visit values of 4.89 and 4.90, respectively. There was no statistically significant improvement in APB strength between groups at any of the postoperative time points (Table 7). Overall grip strength, as measured by dynamometry, did not significantly differ between groups at any of the postoperative time points. As expected, patients in both groups had decreased grip strength in the early postoperative period but reached near preoperative grip strength values at the conclusion of the study (Table 8). Ultimately, we found no differences in pain, 2-point discrimination, monofilament testing, thenar abduction strength, overall grip strength, symptom severity scores, or functional status scores between groups at any of the postoperative time points. Overall satisfaction, where subjects recorded a number from 0 to 100 at the final visit 6 months after the second procedure, was significantly greater in the endoscopic carpal tunnel decompression group (ECTR 95.95 vs OCTR 91.60; P = 0.04), although the objective data we compared do not explain this difference (Table 9). During the final postoperative assessment, if subjects preferred one procedure over another, they were asked to provide an explanation. Subjects who preferred the endoscopic over the open approach [22 (88%) of 25] included comments such as: ‘‘less pain,’’ ‘‘healed faster,’’ ‘‘able to use hand more quickly,’’ ‘‘shorter recovery,’’ and ‘‘invisible scar.’’ Two patients preferred the open procedure, stating: ‘‘less time to heal,’’ and ‘‘no pain at incision site.’’ One subject had no preference. Finally, there were no complications in either group.

DISCUSSION

O-Ave E-Ave P

Preoperative

2 wk

4 wk

8 wk

12 wk

24 wk

2.50 2.66 0.32

1.80 1.74 0.36

1.54 1.51 0.38

1.43 1.31 0.13

1.28 1.23 0.32

1.19 1.21 0.76

* 2014 Lippincott Williams & Wilkins

O-Ave E-Ave P

Preoperative

2 wk

4 wk

8 wk

12 wk

24 wk

6.60 6.92 0.71

6.33 6.16 0.42

6.05 5.04 0.09

5.18 5.00 0.34

4.91 5.13 0.34

4.71 5.11 0.24

www.annalsplasticsurgery.com

Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

S159

Annals of Plastic Surgery

Michelotti et al

TABLE 6. Semmes-Weinstein Monofilament Testing O-Ave E-Ave P

TABLE 9. Patient Satisfaction

Preoperative

2 wk

4 wk

8 wk

12 wk

24 wk

3.78 3.64 0.38

3.49 3.55 0.72

3.33 3.22 0.51

3.37 3.12 0.21

3.20 3.06 0.40

3.11 3.07 0.79

outcome measures including pain, 2-point discrimination, SemmesWeinstein monofilament testing, grip strength, or complications at any of the postoperative time points. At the conclusion of the study, patients were asked how satisfied they were with both the OCTR and the ECTR where they recorded a number from 0 to 100 for each surgery. Patients preferred the endoscopic release, with mean satisfaction scores at the conclusion of the study favoring the endoscopic groupV95.95 versus 91.6. With no differences in any of the variables that were analyzed, the objective data that we have collected cannot be used to explain this difference. Not every subject preferred the endoscopic technique. 92% of subjects preferred endoscopic decompression over the open technique with higher overall satisfaction scores. Commenting on why they preferred this technique, they felt that the ECTR was less painful, had a more favorable scar and they were able to use that hand more quickly. Apart from pain scores, which were objectively no

Preoperative

2 wk

4 wk

8 wk

12 wk

24 wk

4.52 4.50 0.91

4.08 4.22 0.45

4.59 4.61 0.91

4.73 4.74 0.95

4.86 4.87 0.91

4.90 4.89 0.96

different between groups, other stated benefits of the ECTR, according to patient perception, were neither objectively quantified nor compared. Two patients preferred the open procedure, stating: ‘‘less time to heal,’’ and ‘‘no pain at incision site.’’ One subject had no preference. We hypothesize that although the endoscopic surgery is carried out based on the marking of anatomic landmarks preoperatively, rarely the muscle of either the thenar or hypothenar mass is incised. This could contribute to more postoperative pain than incising only the skin, subcutaneous tissue, and the fibers of the transverse carpal ligament. Although the recent meta-analysis suggests that there is a higher incidence of reversible nerve injury in the endoscopic group, we did not observe any postoperative complications in either group. During the course of this study, and with our preliminary analysis suggesting no differences in functional outcomes, the senior author’s (R.M.H.) practice has changed. During preoperative counseling, the topic of anesthetic delivery and expectations has become a point of discussion. Recent advances in the science of wide-awake hand surgery by Lalonde et al have detailed the ability to perform most of hand surgery techniques with lidocaine with epinephrine aloneVavoiding the use of a tourniquet, sedation, or general inhalational anesthetic. Lalonde has demonstrated excellent results and safety in many hand surgery procedures including carpal tunnel release, trigger fingerVA1 pulley release, flexor tendon TABLE 8. Grip Strength O-Ave E-Ave P

S160

O-Ave E-Ave P

91.60 95.95 0.04

repair, Dupuytren disease, and tendon transfers.11Y17 Many patients prefer local anesthesia alone because of the perceived benefits associated with avoidance of sedation or general anesthesia, especially the ability to transport themselves to and from the surgery. At this time, we are performing most OCTRs via the wide-awake local anesthesia technique and if patients request this procedure they are excluded from the study.

CONCLUSIONS This interim analysis, using the same patient as an internal control, suggests that both OCTR and ECTR are tolerated well with no differences in symptom severity and functional status questionnaires, objective outcome measures, or complications. Although there were no differences between groups using our study metrics, patients still preferred the ECTR, with significantly higher overall satisfaction scores at the conclusion of the study. To achieve statistical power, we will continue to enroll patients to reach the number needed to reveal a clinically significant difference in our primary outcome of interest: CTS-SSS and CTS-FSS. REFERENCES

TABLE 7. APB Strength O-Ave E-Ave P

& Volume 73, Supplement 2, December 2014

Preoperative

2 wk

4 wk

8 wk

12 wk

24 wk

16.56 15.20 0.55

9.42 10.72 0.52

12.55 13.65 0.58

13.73 14.90 0.56

14.09 15.33 0.52

15.81 15.79 0.99

www.annalsplasticsurgery.com

1. Einhorn N, Leddy JP. Pitfalls of endoscopic carpal tunnel release. Orthop Clin North Am. 1996;27:373Y380. 2. Newport ML. Upper extremity disorders in women. Clin Orthop Relat Res. 2000;372:85Y94. 3. Agee JM, McCarroll HR Jr, Tortosa RD, et al. Endoscopic release of the carpal tunnel: a randomized prospective multicenter study. J Hand Surg. 1992;17:987Y995. 4. Agee JM, McCarroll HR, North ER. Endoscopic carpal tunnel release using the single proximal incision technique. Hand Clin. 1994;10:647Y659. 5. Agee JM, Peimer CA, Pyrek JD, et al. Endoscopic carpal tunnel release: a prospective study of complications and surgical experience. J Hand Surg. 1995;20:165Y171; discussion 172. 6. Thoma A, Veltri K, Haines T, et al. A meta-analysis of randomized controlled trials comparing endoscopic and open carpal tunnel decompression. Plast Reconstr Surg. 2004;114:1137Y1146. 7. Sanati KA, Mansouri M, Macdonald D, et al. Surgical techniques and return to work following carpal tunnel release: a systematic review and meta-analysis. J Occup Rehabil. 2011;21:474Y481. 8. Cowan J, Makanji H, Mudgal C, et al. Determinants of return to work after carpal tunnel release. J Hand Surg. 2012;37:18Y27. 9. Sennwald GR, Benedetti R. The value of one-portal endoscopic carpal tunnel release: a prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 1995;3:113Y116. 10. Dumontier C, Sokolow C, Leclercq C, et al. Early results of conventional versus two-portal endoscopic carpal tunnel release. A prospective study. J Hand Surg Br. 1995;20:658Y662. 11. Gregory S, Lalonde DH, Fung Leung LT. Minimally invasive finger fracture management: wide-awake closed reduction, K-wire fixation, and early protected movement. Hand Clin. 2014;30:7Y15. 12. Lalonde DH. Wide-awake flexor tendon repair. Plast Reconstr Surg. 2009; 123:623Y625. 13. Lalonde DH, Martin AL. Wide-awake flexor tendon repair and early tendon mobilization in zones 1 and 2. Hand Clin. 2013;29:207Y213. 14. Lalonde D. Minimally invasive anesthesia in wide awake hand surgery. Hand Clin. 2014;30:1Y6. 15. Lalonde DH. Reconstruction of the hand with wide awake surgery. Clin Plast Surg. 2011;38:761Y769. 16. Lalonde DH. ‘‘Hole-in-one’’ local anesthesia for wide-awake carpal tunnel surgery. Plast Reconstr Surg. 2010;126:1642Y1644. 17. Nelson R, Higgnis A, Conrad J, et al. The wide-awake approach to Dupuytren’s disease: fasciectomy under local anesthetic with epinephrine. Hand (N Y). 2010;5:117Y124.

* 2014 Lippincott Williams & Wilkins

Copyright © 2014 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

Prospective, randomized evaluation of endoscopic versus open carpal tunnel release in bilateral carpal tunnel syndrome: an interim analysis.

Most randomized trials have shown similar results with endoscopic carpal tunnel release (ECTR) and open carpal tunnel release (OCTR); however, there a...
189KB Sizes 0 Downloads 4 Views