Schmidt 2014.
Methods | RCT | |
Participants | 54 people (mean age 49.3 years, range 20 to 74; 32 males, 22 females) with 56 clinical, electrophysiological, and ultrasonographic confirmed cases of ulnar nerve neuropathy
Exclusion criteria: contraindications for general anaesthesia, post‐traumatic cubital tunnel syndrome with bony deformity of the elbow, previous surgery of the affected ulnar nerve, severe nerve luxation Investigators appear to have randomised arms rather than participants. |
|
Interventions | Endoscopic decompression (29 arms), open decompression (27 arms) | |
Outcomes | Clinical outcomes:
Electrophysiological outcome: motor nerve conduction velocity |
|
Conflicts of interest | Report states: "The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article." | |
Study funding | No information provided. | |
Notes | Operations were performed between October 2008 and April 2011. Single centre in Germany. Early follow‐up at mean of 16 weeks and long‐term follow‐up at mean of 16.8 months | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The randomization process was performed as a simple randomization without restrictions by drawing a trial envelope by the surgeon directly before each surgery started" |
Allocation concealment (selection bias) | Unclear risk | Quote: "The randomization process was performed as a simple randomization without restrictions by drawing a trial envelope by the surgeon directly before each surgery started" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded examiners performed the postoperative evaluation and statistical analysis. |
Incomplete outcome data (attrition bias) Clinical or neurophysiological outcome | Low risk | 3 participants were free of symptoms at follow‐up and declined further electrophysiological examination. |
Selective reporting (reporting bias) | Low risk | Results from all the outcome measures are reported. |
Other bias | Low risk | The sample size was not calculated. The authors do not specify if the study was designed to be a non‐inferiority or a superiority trial. It is unclear whether any adjustment was made for the 2 bilateral cases (3.7%), but unlikely to have an important effect. |