EVIDENCE-BASED MEDICINE REVIEWS
Evidence-Based Hand and Upper Extremity Surgery Bryan Chung, MD, PhD, Brent Graham, MD, MSc Moosmayer S, Lund G, Seljom US, et al. Tendon repair compared with physiotherapy in the treatment of rotator cuff tears. J Bone Joint Surg Am. 2014;96(18):1504e1514. Level I—Therapeutic trial. Summary: The purpose of this study was to compare the 5-year results of small- to medium-sized rotator cuff tears treated with primary surgical repair with the results of a program of physical therapy. Patients assigned to nonsurgical therapy were given an opportunity to cross over to the surgical treatment arm if their condition did not improve after a course or therapy composed of at least 15 treatment sessions. Eventually, 24% of patients in the nonsurgical treatment arm underwent surgical treatment and were assessed with the physical therapy group. Findings indicated that primary surgical treatment outcomes were better than for physical therapy alone or for surgical treatment after a failed course of nonsurgical treatment. However, the differences were small and below the minimally clinically important difference for the 2 main outcome measures: the Constant score and the American Shoulder and Elbow Surgeons score. The authors concluded that these tears could be managed with therapy as a primary treatment with surgical treatment considered if symptoms failed to resolve. They cautioned that nonsurgical treatment is associated with extension of the tear in 37% of cases and that these larger tears have a poorer outcome after surgical treatment. Science: The randomized trial design was scrupulously implemented, as reflected in the 98% followup rate 5 years after the study was started. Inclusion From Toronto Western Hospital, Toronto, Ontario, Canada. Received for publication April 3, 2015; accepted in revised form April 4, 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: Brent Graham, MD, MSc, Hand Program, Toronto Western Hospital, 399 Bathurst Street, Toronto, Ontario M5T 2S8, Canada; e-mail: [email protected]. 0363-5023/15/4006-0035$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2015.04.006
1260
r
Ó 2015 ASSH
r
Published by Elsevier, Inc. All rights reserved.
and exclusion criteria were appropriate and all patients underwent the same imaging studies, including both magnetic resonance imaging and ultrasound. The primary outcome assessor was blinded to the treatment arm. The outcome measures used are both valid and reliable, although estimates of the minimally clinically important difference are variable for the American Shoulder and Elbow Surgeons score. Use of the intention-to-treat principle was both methodologically appropriate and reflective of clinical practice. Although the authors described the pragmatic nature of the study, meaning the absence of rigid standardization of both surgical and physical therapy protocols, as a potential weakness, in fact this improves the generalizability of the findings. Implications: Despite the high-quality nature of this study, it does not necessarily help clarify the best management of a small- to medium-sized rotator cuff tear. Although it appears that a course of nonsurgical treatment followed by surgical management if symptoms do not resolve results in an outcome close to that achieved after primary surgical repair, there is a risk of tear progression that may lead to a less satisfactory result after surgical treatment that is delayed. This suggests that patient preference should have an important role in choosing treatment, because there appear to be important advantages and disadvantages of both treatment options. Petrigliano FA, Bezrukov N, Gamradt SC, et al. Factors predicting complication and reoperation rates following surgical fixation of proximal humeral fractures. J Bone Joint Surg Am. 2014;96(18): 1544e1551. Level IV—Therapeutic trial. Summary: The article reports the results of evaluating a large administrative database from the California Office of Statewide Health Planning and Development. The objective was to evaluate complications and reoperation rates for patients undergoing nonarthroplasty fixation procedures for fractures of the proximal humerus. The study showed that short- and intermediate-term complications were relatively low
EVIDENCE-BASED MEDICINE REVIEWS
double-blind, placebo-controlled trial. Bone Joint J. 2014;96-B(8):1070e1076. Level II—Therapeutic trial.
but were somewhat higher in males, those aged over 65 years, patients with comorbidities, and those from lower socioeconomic groups. Among the important findings was a relatively low rate of mortality, 3.5%. Pulmonary embolism in the first 90 days after treatment was recorded in only 0.5% of patients. Conversion to either hemiarthroplasty or total shoulder arthroplasty took place in only 2.2% of cases. An interesting additional finding was that over the time period captured by the study, there was a 56% increase in the treatment of proximal humeral fractures with internal fixation, whereas during the same period the population aged over 65 years increased by only 15%. The authors noted that about half of the cases were patients from the highest socioeconomic quintile. They hypothesized that these patients might have had better access to care and were possibly more satisfactory surgical candidates because of better general health.
Summary: This study was a randomized controlled trial comparing pulsed electromagnetic field exposure with placebo in acute scaphoid fractures. Inclusion criteria were adults (aged 18 y and older) within 5 days of injury and unilateral undisplaced fractures of Herbert type A1, A2, B1, or B2. Exclusion criteria were pregnant patients, those with displaced fractures, Herbert type B3, B4, or B5 (proximal pole, fracture-dislocation, or comminuted) implanted electronic devices for lifesaving purposes, additional fractures of the wrist or hand or preexisting wrist impairment, or operative management of the fracture within 5 days of injury. The device was placed over the fracture site and incorporated into the cast. Patients, investigators, and assessors were blinded to the study protocol because devices were randomly disabled by the manufacturer. The primary outcome of this study was time to radiographic evidence of union as measured by computed tomography scan. Secondary outcomes included snuffbox tenderness, pain on longitudinal compression, wrist range of motion, and grip strength. The trial was designed to detect a 30% reduction in time to union. Subjects underwent computed tomography scans at 6, 9, 12, 24, and 52 weeks. The device was in place for 6 weeks. The investigators did not find evidence of faster time to union between groups. There was also no evidence to support a decreased nonunion rate (assessed at 24 wk) or to support a meaningful difference between groups in any of the secondary outcomes. Median time to clinical union was 6 weeks in both groups. Median time to radiographic union was 6 weeks in the active group, compared with 12 weeks in the placebo group; however, the log-rank test yielded a P value of .975. Four subjects were defined as having nonunions in the active group, compared with 2 subjects in the placebo group, but this was also not statistically significant.
Science: The authors used a statewide database of hospital discharges over an 11-year period. The basis for identifying complications, reoperations, and comorbidities was International Classification of Diseases, Ninth Revision codes, a well-established and valid approach for this type of investigation. Logistic regression modeling was used to establish the odds ratio for the various predictor variables. Over 11,000 patients were included in the study. The main limitations to the methodology used relate to the nature of the administrative database and included an inability to define laterality—it was assumed that reoperations were for the index injury rather than for a new fracture on the contralateral side; the absence of any way to differentiate among different fracture types or to determine the exact nature of the internal fixation used; and the exclusion of complications that did not require admission to a hospital. These limitations are typical for any investigations using a database of this nature; however, the impact of these shortcomings is often reduced by the large amount of available data.
Science: This was a well-designed trial to detect possible superiority between active and placebo groups. Strengths of this study included its randomized nature and the robustness of blinding, although the authors did not report on who had access to the random allocation or how the sequence itself was concealed. The absence of an effect on the time to clinical union appears to be based on fairly strong evidence in that all compared outcomes (both primary and secondary) did not appear to exhibit meaningful or statistical differences. Despite these strengths, however, difference in time to radiographic union between the 2 groups at 6 weeks was substantial and
Implications: Administrative databases such as the one used in this study can provide valuable insights into some common conditions. In this instance, several important facts regarding risks of treatment of internal fixation have been established that should help surgeons counsel patients considering this kind of treatment. Hannemann PF, van Wezenbeek MR, Kolkman KA, et al. CT scan-evaluated outcome of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a randomised, multicentre, J Hand Surg Am.
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EVIDENCE-BASED MEDICINE REVIEWS
clinically relevant (47% in the treatment group vs 37% in the placebo group). The inability to detect this difference statistically could be attributed to a lack of power because this study was not designed as a noninferiority trial.
(SD, 1.31 mm), compared with 9.4 mm (SD, 1.42 mm) in the control group. Return of normal sensation in the donor site was reported in 6 fingers. Science: This was a descriptive study primarily outlining the surgical technique of raising a pedicle nerve graft on the second dorsal metacarpal artery. This graft was used for defects involving either or both proper digital nerves in the thumb. The results appeared to be an improvement over reconstructions performed with nonvascularized nerve grafts in the 4 years before the development of this technique. However, average surgical time was 3.6 hours (range, 3e5 h). The authors did not comment on how well the numbness in the donor site was tolerated, nor were there comparisons between the vascularized nerve graft and other commonly used options for larger digital nerve defects, such as nerve conduits or vein grafts. Although the authors conclude that this technique can be used for defects up to 4 cm, the longest defect in this case series was 3.2 cm.
Implications: This study shows that there is a lack of evidence to support the use of pulsed electromagnetic field therapy in decreasing time to union of undisplaced scaphoid fractures of Herbert types A1, A2, B1, and B2. Further studies to determine whether pulsed electromagnetic field therapy has a role in decreasing time to radiographic union would be required in adequately powered trials. Chen C, Tang P, Zhang X. Reconstruction of proper digital nerve defects in the thumb using a pedicle nerve graft. Plast Reconstr Surg. 2012;130(5): 1089e1097. Level IV—Therapeutic trial. Summary: This was a case series of 16 patients with defects in one or both proper digital nerves of the thumb who underwent reconstruction with a vascularized pedicle nerve graft from the dorsal branch of the proper digital nerve of the index and/or middle finger based on the second dorsal metacarpal artery. The lengths of the defects ranged from 1.8 to 3.2 cm, with an average of 2.5 cm. Ten cases involved defects of both radial and ulnar digital nerves and 6 involved only 1 of the 2 digital nerves. The mean length of pedicle grafts was 2.7 cm. Twelve patients received a pedicle nerve graft immediately after injury whereas 4 had reconstructions 3 months after injury. The cause of injury was either crush or avulsion in all cases with a mix of concomitant injuries such as flexor tendons, fractures, and/or arterial damage producing thumb ischemia. Inclusion criteria were: (1) a nerve defect between the thumb distal phalanx and the metacarpophalangeal joint, (2) an injury of one or both digital nerves in the thumb, and (3) a defect size of 1 to 4 cm. Patients who had an injury to the pedicle or donor site and who had no Doppler signal at the location of the second metacarpal artery were excluded. As a control group, 27 patients who had grafts from the sural or medial antebrachial cutaneous nerves were used as historical controls. The primary outcome was sensation of the thumb pulp as measured by static 2-point discrimination and Semmes-Weinstein monofilament testing. The length of follow-up for patients in both group ranged from 19 to 26 or 27 months, with a mean follow-up of 22 and 23 months for the experimental and control groups, respectively. Average 2-point discrimination in the pedicle graft group was 6.7 mm
J Hand Surg Am.
Implications: This study describes a novel technique for raising a pedicle vascularized nerve graft on the second dorsal metacarpal artery to reconstruct moderate defects of the proper digital nerves of the thumb. Although inclusion criteria allowed for defects up to 4 cm, the longest defect in this case series was 3.2 cm; therefore, extension of these results for greater defects is not possible. Its role in reconstruction of thumb nerve defects is not entirely clear because no comparison was performed with other reconstructive options that do not sacrifice donor nerves. Costa ML, Achten J, Parsons NR, et al. Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial. BMJ. 2014 Aug 5;349:g4807. http:// dx.doi.org/10.1136/bmj.g4807. Level II—Therapeutic trial. Summary: This randomized controlled trial compared Kirschner wire with volar locking plate fixation in patients with dorsally displaced distal radius fractures within 3 cm of the radiocarpal joint. The article did not clearly specify whether this was done open or percutaneously. Some of the fracture may have had intra-articular involvement, but this was also not entirely clear. The primary outcome of the study was the Patient-Rated Wrist Evaluation (PRWE). The Disabilities of the Arm, Shoulder, and Hand questionnaire and the EuroQoL 5D questionnaire were secondary outcomes. Complications were also measured. Patients were excluded if the fracture was
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Vol. 40, June 2015
EVIDENCE-BASED MEDICINE REVIEWS
Summary: This article reports a meta-analysis of results of endoscopic and open carpal tunnel release compared in randomized trials. Over 1,800 patients were included in the analysis, which incorporated a variety of outcome measures, postoperative complications and impairment measures such as digit sensibility. The findings showed no difference between the 2 approaches to carpal tunnel release, except for a mild advantage in endoscopic release in avoiding scar tenderness. However, nerve injuries, which are usually but not always transient in nature, were 3 times more common after endoscopic carpal tunnel release than an open approach.
open, extended more than 3 cm from the radiocarpal joint, or could not be reduced in a closed fashion. Over 1.5 years, 461 patients were randomized to receive either pin or plate fixation. Patients were recruited from 18 centers across the United Kingdom. The surgeries were performed by 244 surgeons. The median number of surgeries per surgeon was 1 (interquartile range, 1e2). Patients were administered outcome measures at 3, 6, and 12 months. There was no evidence of superiority of either group at any time, although the primary end point was 12 months after surgery. Subgroup analysis of patients aged older and younger than 50 years as well as patients who had intra-articular involvement did not yield evidence to support the superiority of either technique. At the 12month mark, hand and wrist function was still about 15% worse than patient-recalled pre-injury PRWE scores collected before surgery in both groups.
Science: The usual reason for performing a metaanalysis is that existing randomized trials are either underpowered or have conflicting results, a situation that does not really pertain to the question of the superiority of either approach to carpal tunnel release. The literature has been clear that there is no important advantage to endoscopic carpal tunnel release. The authors justify this study by indicating that they have included analyses of pillar pain and operative time. The study design was well implemented and the data were carefully analyzed. The authors rated the methodological quality of the studies using the CONSORT criteria, but it does not appear that the highest-quality studies were weighted more heavily in the analysis, a strategy that would have been both justified and desirable. In most included studies the principal outcome measure was the well-validated Boston Carpal Tunnel Questionnaire. The findings showed no differences between endoscopic and open carpal tunnel release for overall improvement in symptoms, strength at 6 months, digital sensibility measured using Semmes-Weinstein monofilaments, and occurrence of pillar pain after treatment. Endoscopic treatment took an average of 5 minutes less than open carpal tunnel release. Although scar tenderness was less common after endoscopic release, the risk of nerve injury was 3 times greater. The authors reported that most nerve injuries were “temporary neurapraxias.”
Science: This was a well-designed trial examining percutaneous pinning and volar locking plate fixation of dorsally displaced distal radius fractures. Strengths of this study include the rigor of randomization, blinding of assessors to the study protocol, and allocation concealment as well as stratification by center, age, and intra-articular involvement. Main weaknesses of this study were the large number of surgeons contributing to a single case to the study and the lack of objective outcome measurements. The direction of bias associated with the large number of participating surgeons is not possible to assess—whether a small group of surgeons was responsible for a large proportion of surgeries in each center, and therefore the possibility of these results being attributable to or generalizable to only those surgeons. In addition, this trial was designed as a superiority trial to detect a 6point difference in the PRWE between groups. Although the differences between groups in the primary outcome did not appear to be clinically relevant, the authors did not report on the ability of the trial to make a non-inferiority conclusion. Implications: This trial demonstrates a lack of evidence to support volar locking plate fixation or percutaneous pinning as a superior technique for the fixation of closed dorsally displaced distal radius fractures extending less than 3 cm from the radiocarpal joint amenable to articular reduction by closed technique.
Implications: The study shows that compared with open carpal tunnel release, there is no advantage to the endoscopic approach. A decreased incidence of the symptom of postoperative scar tenderness is achieved at the expense of a risk of nerve injury 3 times that associated with open release. Even if most nerve complications are transient, this seems a high price to pay for the limited return of a reduced risk of scar tenderness, a condition that is also usually temporary.
Sayegh ET, Stauch RJ. Open versus endoscopic carpal tunnel release: a meta-analysis of randomized trials. Clin Orthop Relat Res. 2015;473(3): 1120e1132. Level I—Therapeutic trial. J Hand Surg Am.
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Evidence-Based Hand and Upper Extremity Surgery Bryan Chung, MD, PhD, Brent Graham, MD, MSc Moosmayer S, Lund G, Seljom US, et al. Tendon repair compared with physiotherapy in the treatment of rotator cuff tears. J Bone Joint Surg Am. 2014;96(18):1504e1514. Level I—Therapeutic trial. Summary: The purpose of this study was to compare the 5-year results of small- to medium-sized rotator cuff tears treated with primary surgical repair with the results of a program of physical therapy. Patients assigned to nonsurgical therapy were given an opportunity to cross over to the surgical treatment arm if their condition did not improve after a course or therapy composed of at least 15 treatment sessions. Eventually, 24% of patients in the nonsurgical treatment arm underwent surgical treatment and were assessed with the physical therapy group. Findings indicated that primary surgical treatment outcomes were better than for physical therapy alone or for surgical treatment after a failed course of nonsurgical treatment. However, the differences were small and below the minimally clinically important difference for the 2 main outcome measures: the Constant score and the American Shoulder and Elbow Surgeons score. The authors concluded that these tears could be managed with therapy as a primary treatment with surgical treatment considered if symptoms failed to resolve. They cautioned that nonsurgical treatment is associated with extension of the tear in 37% of cases and that these larger tears have a poorer outcome after surgical treatment. Science: The randomized trial design was scrupulously implemented, as reflected in the 98% followup rate 5 years after the study was started. Inclusion From Toronto Western Hospital, Toronto, Ontario, Canada. Received for publication April 3, 2015; accepted in revised form April 4, 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: Brent Graham, MD, MSc, Hand Program, Toronto Western Hospital, 399 Bathurst Street, Toronto, Ontario M5T 2S8, Canada; e-mail: [email protected]. 0363-5023/15/4006-0035$36.00/0 http://dx.doi.org/10.1016/j.jhsa.2015.04.006
1260
r
Ó 2015 ASSH
r
Published by Elsevier, Inc. All rights reserved.
and exclusion criteria were appropriate and all patients underwent the same imaging studies, including both magnetic resonance imaging and ultrasound. The primary outcome assessor was blinded to the treatment arm. The outcome measures used are both valid and reliable, although estimates of the minimally clinically important difference are variable for the American Shoulder and Elbow Surgeons score. Use of the intention-to-treat principle was both methodologically appropriate and reflective of clinical practice. Although the authors described the pragmatic nature of the study, meaning the absence of rigid standardization of both surgical and physical therapy protocols, as a potential weakness, in fact this improves the generalizability of the findings. Implications: Despite the high-quality nature of this study, it does not necessarily help clarify the best management of a small- to medium-sized rotator cuff tear. Although it appears that a course of nonsurgical treatment followed by surgical management if symptoms do not resolve results in an outcome close to that achieved after primary surgical repair, there is a risk of tear progression that may lead to a less satisfactory result after surgical treatment that is delayed. This suggests that patient preference should have an important role in choosing treatment, because there appear to be important advantages and disadvantages of both treatment options. Petrigliano FA, Bezrukov N, Gamradt SC, et al. Factors predicting complication and reoperation rates following surgical fixation of proximal humeral fractures. J Bone Joint Surg Am. 2014;96(18): 1544e1551. Level IV—Therapeutic trial. Summary: The article reports the results of evaluating a large administrative database from the California Office of Statewide Health Planning and Development. The objective was to evaluate complications and reoperation rates for patients undergoing nonarthroplasty fixation procedures for fractures of the proximal humerus. The study showed that short- and intermediate-term complications were relatively low
EVIDENCE-BASED MEDICINE REVIEWS
double-blind, placebo-controlled trial. Bone Joint J. 2014;96-B(8):1070e1076. Level II—Therapeutic trial.
but were somewhat higher in males, those aged over 65 years, patients with comorbidities, and those from lower socioeconomic groups. Among the important findings was a relatively low rate of mortality, 3.5%. Pulmonary embolism in the first 90 days after treatment was recorded in only 0.5% of patients. Conversion to either hemiarthroplasty or total shoulder arthroplasty took place in only 2.2% of cases. An interesting additional finding was that over the time period captured by the study, there was a 56% increase in the treatment of proximal humeral fractures with internal fixation, whereas during the same period the population aged over 65 years increased by only 15%. The authors noted that about half of the cases were patients from the highest socioeconomic quintile. They hypothesized that these patients might have had better access to care and were possibly more satisfactory surgical candidates because of better general health.
Summary: This study was a randomized controlled trial comparing pulsed electromagnetic field exposure with placebo in acute scaphoid fractures. Inclusion criteria were adults (aged 18 y and older) within 5 days of injury and unilateral undisplaced fractures of Herbert type A1, A2, B1, or B2. Exclusion criteria were pregnant patients, those with displaced fractures, Herbert type B3, B4, or B5 (proximal pole, fracture-dislocation, or comminuted) implanted electronic devices for lifesaving purposes, additional fractures of the wrist or hand or preexisting wrist impairment, or operative management of the fracture within 5 days of injury. The device was placed over the fracture site and incorporated into the cast. Patients, investigators, and assessors were blinded to the study protocol because devices were randomly disabled by the manufacturer. The primary outcome of this study was time to radiographic evidence of union as measured by computed tomography scan. Secondary outcomes included snuffbox tenderness, pain on longitudinal compression, wrist range of motion, and grip strength. The trial was designed to detect a 30% reduction in time to union. Subjects underwent computed tomography scans at 6, 9, 12, 24, and 52 weeks. The device was in place for 6 weeks. The investigators did not find evidence of faster time to union between groups. There was also no evidence to support a decreased nonunion rate (assessed at 24 wk) or to support a meaningful difference between groups in any of the secondary outcomes. Median time to clinical union was 6 weeks in both groups. Median time to radiographic union was 6 weeks in the active group, compared with 12 weeks in the placebo group; however, the log-rank test yielded a P value of .975. Four subjects were defined as having nonunions in the active group, compared with 2 subjects in the placebo group, but this was also not statistically significant.
Science: The authors used a statewide database of hospital discharges over an 11-year period. The basis for identifying complications, reoperations, and comorbidities was International Classification of Diseases, Ninth Revision codes, a well-established and valid approach for this type of investigation. Logistic regression modeling was used to establish the odds ratio for the various predictor variables. Over 11,000 patients were included in the study. The main limitations to the methodology used relate to the nature of the administrative database and included an inability to define laterality—it was assumed that reoperations were for the index injury rather than for a new fracture on the contralateral side; the absence of any way to differentiate among different fracture types or to determine the exact nature of the internal fixation used; and the exclusion of complications that did not require admission to a hospital. These limitations are typical for any investigations using a database of this nature; however, the impact of these shortcomings is often reduced by the large amount of available data.
Science: This was a well-designed trial to detect possible superiority between active and placebo groups. Strengths of this study included its randomized nature and the robustness of blinding, although the authors did not report on who had access to the random allocation or how the sequence itself was concealed. The absence of an effect on the time to clinical union appears to be based on fairly strong evidence in that all compared outcomes (both primary and secondary) did not appear to exhibit meaningful or statistical differences. Despite these strengths, however, difference in time to radiographic union between the 2 groups at 6 weeks was substantial and
Implications: Administrative databases such as the one used in this study can provide valuable insights into some common conditions. In this instance, several important facts regarding risks of treatment of internal fixation have been established that should help surgeons counsel patients considering this kind of treatment. Hannemann PF, van Wezenbeek MR, Kolkman KA, et al. CT scan-evaluated outcome of pulsed electromagnetic fields in the treatment of acute scaphoid fractures: a randomised, multicentre, J Hand Surg Am.
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r
Vol. 40, June 2015
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EVIDENCE-BASED MEDICINE REVIEWS
clinically relevant (47% in the treatment group vs 37% in the placebo group). The inability to detect this difference statistically could be attributed to a lack of power because this study was not designed as a noninferiority trial.
(SD, 1.31 mm), compared with 9.4 mm (SD, 1.42 mm) in the control group. Return of normal sensation in the donor site was reported in 6 fingers. Science: This was a descriptive study primarily outlining the surgical technique of raising a pedicle nerve graft on the second dorsal metacarpal artery. This graft was used for defects involving either or both proper digital nerves in the thumb. The results appeared to be an improvement over reconstructions performed with nonvascularized nerve grafts in the 4 years before the development of this technique. However, average surgical time was 3.6 hours (range, 3e5 h). The authors did not comment on how well the numbness in the donor site was tolerated, nor were there comparisons between the vascularized nerve graft and other commonly used options for larger digital nerve defects, such as nerve conduits or vein grafts. Although the authors conclude that this technique can be used for defects up to 4 cm, the longest defect in this case series was 3.2 cm.
Implications: This study shows that there is a lack of evidence to support the use of pulsed electromagnetic field therapy in decreasing time to union of undisplaced scaphoid fractures of Herbert types A1, A2, B1, and B2. Further studies to determine whether pulsed electromagnetic field therapy has a role in decreasing time to radiographic union would be required in adequately powered trials. Chen C, Tang P, Zhang X. Reconstruction of proper digital nerve defects in the thumb using a pedicle nerve graft. Plast Reconstr Surg. 2012;130(5): 1089e1097. Level IV—Therapeutic trial. Summary: This was a case series of 16 patients with defects in one or both proper digital nerves of the thumb who underwent reconstruction with a vascularized pedicle nerve graft from the dorsal branch of the proper digital nerve of the index and/or middle finger based on the second dorsal metacarpal artery. The lengths of the defects ranged from 1.8 to 3.2 cm, with an average of 2.5 cm. Ten cases involved defects of both radial and ulnar digital nerves and 6 involved only 1 of the 2 digital nerves. The mean length of pedicle grafts was 2.7 cm. Twelve patients received a pedicle nerve graft immediately after injury whereas 4 had reconstructions 3 months after injury. The cause of injury was either crush or avulsion in all cases with a mix of concomitant injuries such as flexor tendons, fractures, and/or arterial damage producing thumb ischemia. Inclusion criteria were: (1) a nerve defect between the thumb distal phalanx and the metacarpophalangeal joint, (2) an injury of one or both digital nerves in the thumb, and (3) a defect size of 1 to 4 cm. Patients who had an injury to the pedicle or donor site and who had no Doppler signal at the location of the second metacarpal artery were excluded. As a control group, 27 patients who had grafts from the sural or medial antebrachial cutaneous nerves were used as historical controls. The primary outcome was sensation of the thumb pulp as measured by static 2-point discrimination and Semmes-Weinstein monofilament testing. The length of follow-up for patients in both group ranged from 19 to 26 or 27 months, with a mean follow-up of 22 and 23 months for the experimental and control groups, respectively. Average 2-point discrimination in the pedicle graft group was 6.7 mm
J Hand Surg Am.
Implications: This study describes a novel technique for raising a pedicle vascularized nerve graft on the second dorsal metacarpal artery to reconstruct moderate defects of the proper digital nerves of the thumb. Although inclusion criteria allowed for defects up to 4 cm, the longest defect in this case series was 3.2 cm; therefore, extension of these results for greater defects is not possible. Its role in reconstruction of thumb nerve defects is not entirely clear because no comparison was performed with other reconstructive options that do not sacrifice donor nerves. Costa ML, Achten J, Parsons NR, et al. Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial. BMJ. 2014 Aug 5;349:g4807. http:// dx.doi.org/10.1136/bmj.g4807. Level II—Therapeutic trial. Summary: This randomized controlled trial compared Kirschner wire with volar locking plate fixation in patients with dorsally displaced distal radius fractures within 3 cm of the radiocarpal joint. The article did not clearly specify whether this was done open or percutaneously. Some of the fracture may have had intra-articular involvement, but this was also not entirely clear. The primary outcome of the study was the Patient-Rated Wrist Evaluation (PRWE). The Disabilities of the Arm, Shoulder, and Hand questionnaire and the EuroQoL 5D questionnaire were secondary outcomes. Complications were also measured. Patients were excluded if the fracture was
r
Vol. 40, June 2015
EVIDENCE-BASED MEDICINE REVIEWS
Summary: This article reports a meta-analysis of results of endoscopic and open carpal tunnel release compared in randomized trials. Over 1,800 patients were included in the analysis, which incorporated a variety of outcome measures, postoperative complications and impairment measures such as digit sensibility. The findings showed no difference between the 2 approaches to carpal tunnel release, except for a mild advantage in endoscopic release in avoiding scar tenderness. However, nerve injuries, which are usually but not always transient in nature, were 3 times more common after endoscopic carpal tunnel release than an open approach.
open, extended more than 3 cm from the radiocarpal joint, or could not be reduced in a closed fashion. Over 1.5 years, 461 patients were randomized to receive either pin or plate fixation. Patients were recruited from 18 centers across the United Kingdom. The surgeries were performed by 244 surgeons. The median number of surgeries per surgeon was 1 (interquartile range, 1e2). Patients were administered outcome measures at 3, 6, and 12 months. There was no evidence of superiority of either group at any time, although the primary end point was 12 months after surgery. Subgroup analysis of patients aged older and younger than 50 years as well as patients who had intra-articular involvement did not yield evidence to support the superiority of either technique. At the 12month mark, hand and wrist function was still about 15% worse than patient-recalled pre-injury PRWE scores collected before surgery in both groups.
Science: The usual reason for performing a metaanalysis is that existing randomized trials are either underpowered or have conflicting results, a situation that does not really pertain to the question of the superiority of either approach to carpal tunnel release. The literature has been clear that there is no important advantage to endoscopic carpal tunnel release. The authors justify this study by indicating that they have included analyses of pillar pain and operative time. The study design was well implemented and the data were carefully analyzed. The authors rated the methodological quality of the studies using the CONSORT criteria, but it does not appear that the highest-quality studies were weighted more heavily in the analysis, a strategy that would have been both justified and desirable. In most included studies the principal outcome measure was the well-validated Boston Carpal Tunnel Questionnaire. The findings showed no differences between endoscopic and open carpal tunnel release for overall improvement in symptoms, strength at 6 months, digital sensibility measured using Semmes-Weinstein monofilaments, and occurrence of pillar pain after treatment. Endoscopic treatment took an average of 5 minutes less than open carpal tunnel release. Although scar tenderness was less common after endoscopic release, the risk of nerve injury was 3 times greater. The authors reported that most nerve injuries were “temporary neurapraxias.”
Science: This was a well-designed trial examining percutaneous pinning and volar locking plate fixation of dorsally displaced distal radius fractures. Strengths of this study include the rigor of randomization, blinding of assessors to the study protocol, and allocation concealment as well as stratification by center, age, and intra-articular involvement. Main weaknesses of this study were the large number of surgeons contributing to a single case to the study and the lack of objective outcome measurements. The direction of bias associated with the large number of participating surgeons is not possible to assess—whether a small group of surgeons was responsible for a large proportion of surgeries in each center, and therefore the possibility of these results being attributable to or generalizable to only those surgeons. In addition, this trial was designed as a superiority trial to detect a 6point difference in the PRWE between groups. Although the differences between groups in the primary outcome did not appear to be clinically relevant, the authors did not report on the ability of the trial to make a non-inferiority conclusion. Implications: This trial demonstrates a lack of evidence to support volar locking plate fixation or percutaneous pinning as a superior technique for the fixation of closed dorsally displaced distal radius fractures extending less than 3 cm from the radiocarpal joint amenable to articular reduction by closed technique.
Implications: The study shows that compared with open carpal tunnel release, there is no advantage to the endoscopic approach. A decreased incidence of the symptom of postoperative scar tenderness is achieved at the expense of a risk of nerve injury 3 times that associated with open release. Even if most nerve complications are transient, this seems a high price to pay for the limited return of a reduced risk of scar tenderness, a condition that is also usually temporary.
Sayegh ET, Stauch RJ. Open versus endoscopic carpal tunnel release: a meta-analysis of randomized trials. Clin Orthop Relat Res. 2015;473(3): 1120e1132. Level I—Therapeutic trial. J Hand Surg Am.
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