Methods |
RCT |
Participants |
44 people (age range 27 to 83 years; 33 male, 11 female) with signs and symptoms of idiopathic ulnar nerve entrapment, without benefit after conservative treatment and with electrophysiological evidence of the nerve impairment. Exclusion criteria included:
repeat surgery;
prior fracture or dislocation at the elbow;
tumours;
subluxing ulnar nerve syndrome;
unwillingness to participate in the study.
|
Interventions |
Simple decompression (23 participants), submuscular transposition (21 participants) |
Outcomes |
Clinical outcome:
4‐tiered McGowan grading system
6‐tiered Louisiana State University Medical Center (LSUMC) grading system
|
Conflicts of interest |
No information provided. |
Study funding |
No information provided. |
Notes |
Operations were performed between August 1993 and June 1998 by a single surgeon in 2 hospitals in Australia. Follow‐up at 6 weeks and 6 months after surgery |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Computer‐generated random numbers |
Allocation concealment (selection bias) |
Unclear risk |
No allocation concealment method is described. |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Not specified. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Not specified. |
Incomplete outcome data (attrition bias)
Clinical or neurophysiological outcome |
Low risk |
Quote: "Three patients were lost to follow‐up" |
Selective reporting (reporting bias) |
Low risk |
Results from all the outcome measures are reported. |
Other bias |
High 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. |