| Methods |
RCT |
| Participants |
70 people (age range 32 to 75 years; 48 male, 22 female) with severe cubital tunnel syndrome, grade 3 according to Dellon’s staging system. All the participants had electrophysiological evidence of ulnar impairment. Exclusion criteria:
cubitus valgus osseous canal deformity (previous traumatic events or severe osteophytosis of the elbow joint) luxation of the nerve dislocation of the medial portion of the triceps severe medical or anaesthesiological problems, or both
|
| Interventions |
Simple decompression (35 participants), anterior submuscular transposition (35 participants) |
| Outcomes |
Clinical outcome: Bishop rating system, which assesses subjective and objective parameters Electrophysiological outcome:
distal motor latency compound muscle action potential amplitude nerve conduction velocity
|
| Conflicts of interest |
"The authors ... have no personal or institutional financial interest in drugs, materials, or devices described in this study." |
| Study funding |
"The authors have received no financial support in conjunction with the compilation of this study" |
| Notes |
Operations were performed between February 1998 and June 2003 at a single centre in Italy. There were 2 surgeons, each of whom performed the operation in 1 of the 2 groups. Follow‐up at 6 months after surgery |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
High risk |
Quote: "The patients were randomised by use of their reservation numbers in the hospital" |
| 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 |
Low risk |
Quote: "The postoperative outcome, both clinical and electroneuromyographic, was evaluated in all the patients by the same blinded evaluator" |
| Incomplete outcome data (attrition bias)
Clinical or neurophysiological outcome |
Low risk |
No participant lost to follow‐up. |
| Selective reporting (reporting bias) |
Unclear risk |
Pre‐ and postoperative evaluations were performed using 2 different staging systems: preoperatively the authors used the Dellon scale, postoperatively they used the Bishop rating system. |
| Other bias |
High risk |
The sample size was not calculated. Only people with severe disease were included in the study. The authors do not specify if the study was designed to be a non‐inferiority or a superiority trial. |
