Manfred Hofer

Outcomes of endoscopic surgery compared with open surgery for carpal tunnel syndrome among employed patients: randomised controlled trial

Abstract Objectives To compare endoscopic and open carpal tunnel release surgery among employed patients with carpal tunnel syndrome. Design and setting Randomised controlled trial at a single orthopaedic department. Participants 128 employed patients aged 25-60 years with clinically diagnosed and electrophysiologically confirmed idiopathic carpal tunnel syndrome. Main outcome measures The primary outcome was severity of postoperative pain in the scar or proximal palm and the degree to which pain or tenderness limits activities, each rated on a 4 point scale, transformed into a combined score of 0 (none) to 100 (severe pain or tenderness causing severe activity limitation). The secondary outcomes were length of postoperative work absence, severity of symptoms of carpal tunnel syndrome and functional status scores, SF-12 quality of life score, and hand sensation and strength (blinded examiner); follow-up at three and six weeks and three and 12 months. Results 63 patients were allocated to endoscopic surgery and 65 patients to open surgery, with no withdrawals or dropouts. Pain in the scar or proximal palm was less prevalent or severe after endoscopic surgery than after open surgery but the differences were generally small. At three months, pain in the scar or palm was reported by 33 patients (52%) in the endoscopic group and 53 patients (82%) in the open group (number needed to treat 3.4, 95% confidence interval 2.3 to 7.7) and the mean score difference for severity of pain in scar or palm and limitation of activity was 13.3 (5.3 to 21.3). No differences between the groups were found in the other outcomes. The median length of work absence after surgery was 28 days in both groups. Quality of life measures improved substantially. Conclusions In carpal tunnel syndrome, endoscopic surgery was associated with less postoperative pain than open surgery, but the small size of the benefit and similarity in other outcomes make its cost effectiveness uncertain.

Wrist-bridging versus non-bridging external fixation for displaced distal radius fractures: a randomized assessor-blind clinical trial of 38 patients followed for 1 year

Background Non-bridging external fixation has been introduced to achieve better fracture fixation and functional outcomes in distal radius fractures, but has not been specifically evaluated in a randomized study in the elderly. The purpose of this trial was to compare wrist-bridging and non-bridging external fixation for displaced distal radius fractures. Method The inclusion criteria were women ≥ 50 or men ≥ 60 years, acute extraarticular or intraarticular fracture, and dorsal angulation of ≥20° or ulnar variance ≥ 5 mm. The patients completed the disabilities of the arm, shoulder and hand (DASH) questionnaire before and at 10, 26 and 52 weeks after surgery. Pain (visual analog scale), range of motion and grip strength were measured by a blinded assessor. Results 38 patients (mean age 71 years, 31 women) were randomized at surgery (19 to each group). Mean operating time was shorter for wrist-bridging fixation by 10 (95% CI 3–17) min. There was no significant difference in DASH scores between the groups. No statistically significant differences in pain score, range of motion, grip strength, or patient satisfaction were found. The non-bridging group had a significantly better radial length at 52 weeks; mean difference in change in ulnar variance from baseline was 1.4 (95% CI 0.1–2.7) mm (p = 0.04). Volar tilt and radial inclination were similar in both groups. Interpretation For moderately or severely displaced distal radius fractures in the elderly, non-bridging external fixation had no clinically relevant advantage over wrist-bridging fixation but was more effective in maintaining radial length.

Open compared with 2-portal endoscopic carpal tunnel release: a 5-year follow-up of a randomized controlled trial.

PURPOSE The purpose of this investigation was to extend the previously reported short-term randomized trial of open and endoscopic carpal tunnel release in patients with carpal tunnel syndrome (CTS) to compare outcomes 5 years after surgery. METHODS In a single-center randomized controlled trial, 128 patients (25 to 60 years) with clinically diagnosed and electrophysiologically confirmed idiopathic CTS were randomized immediately before surgery to open or 2-portal endoscopic release. The outcome measures included the validated CTS questionnaires symptom severity and functional status scales (scored from 1 to 5) completed at baseline and 1 year postoperatively. At the extended follow-up of the trial 5 years after surgery, 2 patients had died and the other 126 participants (63 patients in each group) completed the CTS questionnaire. RESULTS At the 5-year follow-up no difference between the groups was found in the CTS symptom severity score. The mean (SD) score in the open group was 1.42 (0.7) and in the endoscopic group was 1.45 (0.7), and the mean difference in score change from baseline was 0.03 (95% confidence interval, -0.21 to 0.27). Between 1 year and 5 years postoperatively, the CTS symptom severity score had deteriorated by at least 0.4 point in 9 patients in the open group and in 10 patients in the endoscopic group. The mean (SD) CTS functional status score was 1.29 (0.5) in the open group and 1.30 (0.5) in the endoscopic group. At 5 years, 11 patients in the open group and 10 patients in the endoscopic group reported persistent pain in the scar or proximal palm. Three patients in each group had repeat surgery on the operated hand because of persistent or recurrent symptoms. CONCLUSIONS The improvements in symptoms of CTS and hand-related disability 5 years after open and 2-portal endoscopic carpal tunnel release were equivalent. TYPE OF STUDY/LEVEL OF EVIDENCE Therapeutic I.

Relationship between distal radius fracture malunion and arm-related disability: A prospective population-based cohort study with 1-year follow-up

BackgroundDistal radius fracture is a common injury and may result in substantial dysfunction and pain. The purpose was to investigate the relationship between distal radius fracture malunion and arm-related disability.MethodsThe prospective population-based cohort study included 143 consecutive patients above 18 years with an acute distal radius fracture treated with closed reduction and either cast (55 patients) or external and/or percutaneous pin fixation (88 patients). The patients were evaluated with the disabilities of the arm, shoulder and hand (DASH) questionnaire at baseline (concerning disabilities before fracture) and one year after fracture. The 1-year follow-up included the SF-12 health status questionnaire and clinical and radiographic examinations. Patients were classified into three hypothesized severity categories based on fracture malunion; no malunion, malunion involving either dorsal tilt (>10 degrees) or ulnar variance (≥1 mm), and combined malunion involving both dorsal tilt and ulnar variance. Multivariate regression analyses were performed to determine the relationship between the 1-year DASH score and malunion and the relative risk (RR) of obtaining DASH score ≥15 and the number needed to harm (NNH) were calculated.ResultsThe mean DASH score at one year after fracture was significantly higher by a minimum of 10 points with each malunion severity category. The RR for persistent disability was 2.5 if the fracture healed with malunion involving either dorsal tilt or ulnar variance and 3.7 if the fracture healed with combined malunion. The NNH was 2.5 (95% CI 1.8-5.4). Malunion had a statistically significant relationship with worse SF-12 score (physical health) and grip strength.ConclusionMalunion after distal radius fracture was associated with higher arm-related disability regardless of age.

Methylprednisolone Injections for the Carpal Tunnel Syndrome A Randomized, Placebo-Controlled Trial

BACKGROUND Steroid injections are used in idiopathic carpal tunnel syndrome (CTS), but evidence of efficacy beyond 1 month is lacking. OBJECTIVE To assess the efficacy of local methylprednisolone injections in CTS. DESIGN Randomized, placebo-controlled trial. (ClinicalTrials.gov: NCT00806871). SETTING Regional referral orthopedic department in Sweden. PATIENTS Patients aged 18 to 70 years with CTS but no previous steroid injections. INTERVENTION Three groups (37 patients each) received 80 mg of methylprednisolone, 40 mg of methylprednisolone, or placebo. The patients and treating surgeons were blinded. MEASUREMENTS Primary end points were the change in CTS symptom severity scores at 10 weeks (range, 1 to 5) and rate of surgery at 1 year. Three patients had missing 10-week data. All patients had 1-year data. RESULTS Improvement in CTS symptom severity scores at 10 weeks was greater in patients who received 80 mg of methylprednisolone and 40 mg of methylprednisolone than in those who received placebo (difference in change from baseline, -0.64 [95% CI, -1.06 to -0.21; P = 0.003] and -0.88 [CI, -1.30 to -0.46; P < 0.001], respectively), but there were no significant differences at 1 year. The 1-year rates of surgery were 73%, 81%, and 92% in the 80-mg methylprednisolone, 40-mg methylprednisolone, and placebo groups, respectively. Compared with patients who received placebo, those who received 80 mg of methylprednisolone were less likely to have surgery (odds ratio, 0.24 [CI, 0.06 to 0.95]; P = 0.042). With time to surgery incorporated, both the 80- and 40-mg methylprednisolone groups had lower likelihood of surgery (hazard ratio, 0.46 [CI, 0.27 to 0.77; P = 0.003] and 0.57 [CI, 0.35 to 0.94; P = 0.026], respectively). LIMITATION The study was conducted at 1 center, and wrist splinting had previously failed for all patients. CONCLUSION Methylprednisolone injections for CTS have significant benefits in relieving symptoms at 10 weeks and reducing the rate of surgery 1 year after treatment, but 3 out of 4 patients had surgery within 1 year. PRIMARY FUNDING SOURCE Region of Scania Research and Development Foundation and Hässleholm Hospital Organization.

Fractures of the distal radius in women aged 50 to 75 years: natural course of patient-reported outcome, wrist motion and grip strength between 1 year and 2–4 years after fracture:

Fractures of the distal radius in postmenopausal women may cause prolonged pain and disability, but little is known about their natural course beyond the first year. In this study, women of 50–75 years of age, initially treated with cast or external fixation, were examined 1 year after distal radial fracture and then re-evaluated after a mean of 3 (range, 2–4) years. The evaluation included pain, disability (DASH) scores, grip strength and range of motion. In the 49 participating women pain scores, grip strength and range of motion improved significantly, although the mean improvement was moderate or small. In a subgroup of 13 patients with moderate or severe malunion, the 1 year DASH score was significantly worse than in the remaining patients but improved significantly together with grip strength and range of motion. After fractures of the distal radius, pain, grip strength and range of motion continued to improve beyond 1 year, up to 2–4 years. Patients with malunion had more disability at 1 year but showed significant improvement at 2–4 years.

Local steroid injection for moderately severe idiopathic carpal tunnel syndrome: Protocol of a randomized double-blind placebo-controlled trial (NCT 00806871)

BackgroundPatients with idiopathic carpal tunnel syndrome (CTS) are commonly treated with steroid injection into or proximal to the carpal tunnel. However, evidence for its efficacy beyond one month has not been established in randomized placebo-controlled trials. The primary aim of this randomized trial is to assess the efficacy of steroid injection into the carpal tunnel in relieving symptoms of CTS in patients with symptoms of such severity to warrant surgical treatment but have not been treated with steroid injection.Methods/DesignThe study is a randomized double-blind placebo-controlled trial. Patients referred to one orthopedic department because of CTS are screened. Eligibility criteria are age 18 to 70 years, clinical diagnosis of primary idiopathic CTS and abnormal nerve conduction tests or clinical diagnosis made independently by two orthopedic surgeons, failed treatment with wrist splinting, symptom severity of such magnitude that the patient is willing to undergo surgery, no severe sensory loss or thenar muscle atrophy, and no previous steroid injection for CTS. A total of 120 patients will be randomized to injection of 80 mg Methylprednisolone, 40 mg Methylprednisolone, or normal saline, each also containing 10 mg Lidocaine. Evaluation at baseline and at 5, 10, 24 and 52 weeks after injection includes validated questionnaires (CTS symptom severity scale, Quick DASH and SF-6D), adverse events, physical examination by a blinded assessor, and nerve conduction tests. The primary outcome measures are change in the CTS symptom severity score at 10 weeks and the rate of surgery at 52 weeks. The secondary outcome measures are the score change in the CTS symptom severity scale at 52 weeks, time to surgery, and change in Quick DASH and SF-6D scores and patient satisfaction at 10 and 52 weeks. The primary analysis will be carried out using mixed model analysis of repeated measures.DiscussionThis paper describes the rationale and design of a double-blind, randomized placebo-controlled trial that aims to determine the efficacy of two different doses of steroid injected into the carpal tunnel in patients with moderately severe idiopathic CTS.Trial registrationClinicaltrials.gov identifier NCT00806871

Extended Follow-up of a Randomized Clinical Trial of Open vs Endoscopic Release Surgery for Carpal Tunnel Syndrome

efforts and pay-for-performance initiatives. Considering the burden of revisits to patients and hospitals following ambulatory operations, our study highlights the importance of expanding health policy and clinical interventions to include ambulatory surgery and complications assessed in the ED. Future work should determine associated risk factors and which complications are potentially preventable.