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. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4
Methods RCT
Experimental group (Exp): Trapeziectomy with LRTI (APL)
Control group (C): Trapeziectomy
Participants Age (mean): Exp/C = 58/63
Gender (female/male): Exp/C = 19:4/18:1
Stage of OA (mean): Exp/C = 3.0/3.5
Interventions Surgery Exp/C:
Exp: Trapeziectomy with LRTI (using dorsal slip of APL). Postoperative backslab, then customised splint fitted at 2 weeks, including wrist in extension, thumb trapeziometacarpal joint in abduction and metacarpophalangeal joint in extension. Gentle mobilisation at 4 weeks, splint discharged at 6 weeks.
C: Trapeziectomy. Postoperative backslab, then customised splint fitted at 2 weeks, including wrist in extension, thumb trapeziometacarpal joint in abduction and metacarpophalangeal joint in extension. Gentle mobilisation at 4 weeks, splint discharged at 6 weeks.
Outcomes Pain: A 10 cm VAS was used to assess thumb pain, with '0' indicating no pain and '10' terrible pain. Physical function: A 100 mm VAS was used to score 'how well the hands work generally', with '0' indicating full function and '10' no use. Patient global assessment: Not reported. Range of motion: Trapeziometacarpal extension (radial abduction) and abduction (palmar abduction) were measured as the distance between the thumb interphalangeal joint crease and the palmar crease. Strength: Grip strength was measured with the Jamar dynamometer, and pulp (2 point) and key (lateral) pinch were measured with a pinch‐meter and measured in kg. Trapeziometacarpal joint imaging: Measurement of the distance between the base of the thumb metacarpal and the distal end of the scaphoid were reported as the scapho‐metacarpal distance in mm. The distance between the base of the thumb metacarpal and the radial border of the trapezoid were reported as trapeziometacarpal distance in mm. Adverse events: Complications of recurrent pain, instability, neuroma, sensory loss and tendon (FCR) rupture were reported.
Notes Follow‐up at 14 months (7 to 29).
We tried to contact a trial author. No further information was provided.
Two review authors (AW and EC) calculated SD from standard error (SE) values provided.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomised by spinning a coin".
Allocation concealment (selection bias) Low risk Comment: Randomisation performed after trapezium was completely excised.
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Comment: Unclear if participants or assessors were informed of surgery performed prior to final review.
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. We cannot exclude observer bias in recording outcomes (e.g. rounding up or down) as we do not know if they were blinded until final review.
Incomplete outcome data (attrition bias) All outcomes Unclear risk Quote: "one patient was lost to follow up [at 14 months]".
Comment: Unclear which operation the patient lost to follow‐up received.
Selective reporting (reporting bias) Unclear risk Comment: No protocol identified.