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. 2016 Nov 15;2016(11):CD006839. doi: 10.1002/14651858.CD006839.pub4

Biggs 2006.

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:
  1. repeat surgery;

  2. prior fracture or dislocation at the elbow;

  3. tumours;

  4. subluxing ulnar nerve syndrome;

  5. unwillingness to participate in the study.

Interventions Simple decompression (23 participants), submuscular transposition (21 participants)
Outcomes Clinical outcome:
  1. 4‐tiered McGowan grading system

  2. 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.