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. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4
Methods RCT
Exp: Trapeziectomy with LRTI (FCR)
C: Trapeziectomy with ligament reconstruction with Mitek suture anchor
Participants Age (mean): Exp/C = 61/62
Gender: Exp/C = 9/11
Stage of OA (mean): Exp/C = not stated
Number of subjects: Exp/C = 9/11
Interventions Surgery Exp/C:
Exp: Trapeziectomy with LRTI (FCR)
C: Trapeziectomy with ligament reconstruction (no rolled tendon spacer used to place within the void of the resected trapezium). Post‐operative management not stated
Outcomes Pain: Not reported
Physical function: Subjective overall satisfaction with the procedure was reported for the 2 groups
Patient global assessment: Not reported
Range of motion: Radial and palmar abduction were measured in degrees and the ability of the thumb to touch the volar aspect of the 5th MP joint was recorded at 23 months follow‐up.
Strength: Grip strength was measured with the Jamar dynamometer, and 2 point and 3 point pinch strength were measured with a pinch‐meter at 23 month follow‐up and measured in kg.
Trapeziometacarpal joint imaging: The height of the reconstructed basal joint (scapho‐metacarpal distance) was measured on lateral radiographs both at rest and during pinch.
Adverse events: Not reported
Notes Average follow‐up of 23 months
We tried to contact one of the trial authors but no further information was provided.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "patients were randomised to one of two groups".
Comment: Method of randomisation sequence generation was not stated.
Allocation concealment (selection bias) Unclear risk
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Quote: "Patients returned for blind assessment".
Comment: Unclear who was blinded or how they were blinded.
Blinding of outcome assessment (detection bias) Subjective outcomes (patient reported) Unclear risk Comment: Unclear if participants were informed of surgery performed prior to final review.
Blinding of outcome assessment (detection bias) Objective outcomes Unclear risk Comment: Unclear if participants were informed of surgery prior to final review. Observer bias in recording outcomes cannot be excluded (e.g. rounding up or down) as it is unknown if they were blinded until final review.
Incomplete outcome data (attrition bias) All outcomes Unclear risk Comment: No comment on if all enrolled participants were reviewed or if any were lost to follow‐up.
Selective reporting (reporting bias) Unclear risk We did not identify a protocol.