Kriegs‐Au 2004

Methods	RCT Exp: Trapeziectomy with LRTI (FCR) C: Trapeziectomy with ligament reconstruction alone
Participants	Age (mean): Exp/C = 58/59 Gender (female/male): Exp/C = 12:4/13:2 Stage of OA (number of subjects): Exp/C = Exp: 3 Stage II, 11 Stage III, 2 Stage IV / C: 2 Stage II, 11 Stage III, 2 Stage IV
Interventions	Surgery Exp/C: Exp: Trapeziectomy with LRTI (using FCR). Postoperative spica cast for 3 weeks, replaced with customised thumb spica splint until 6 weeks. Active and active‐assisted ROM and thenar strengthening exercises begun at 6 weeks. C: Trapeziectomy with ligament reconstruction (no tendon interposition). Postoperative spica cast for 3 weeks, replaced with customised thumb spica splint until 6 weeks. Active and active‐assisted ROM and thenar strengthening exercises begun at 6 weeks.
Outcomes	Pain: Number of subjects reporting pain at rest and during strain are reported preoperatively, with pain frequency (never, occasional, frequent, constant) reported postoperatively. Physical function: The number of subjects reporting moderate difficulty with activities of daily living (writing, brushing teeth, threading needle, turning key, opening tight jar, using knife or scissors, buttoning clothes, zipping clothes, picking up small objects, and playing cards) are reported. Patient global assessment: Overall assessment of subjective outcomes were assessed with the grade of the total Buck‐Gramcko score, with scores of 49 to 56/56 achieving an 'excellent' result, 40 to 48/56 'good', 28 to 39/56 'fair' and < 28/56 'poor'. Range of motion: Mean palmar and radial abduction were measured in degrees with a goniometer, and opposition (the ability to touch the palmar crease of the little finger with thumb tip), were measured both preoperatively and at final follow‐up. Strength: Grip strength was measured with the Martin vigorimeter, and tip (2 point) pinch was measured with a pinch‐meter, and measured in bar (Pa). Trapeziometacarpal joint imaging: Standard PA and oblique radiographs were performed preoperatively and at follow‐up. The index of the height of the arthroplasty space was calculated by dividing the scapho‐metacarpal distance by the length of the 1st metacarpal. The index was calculated both at rest and under stress postoperatively. Adverse events: Complications of nerve irritation and Reflex Sympathetic Dystrophy were reported.
Notes	Average 48.2 months follow‐up (15 to 120) Attempt was made to contact author. No further information was provided. Two of our authors (AW and EC) calculated SDs using means, sample size for each group and exact P value for (2‐tailed) difference between groups.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "computer‐generated randomization list"
Allocation concealment (selection bias)	Unclear risk	Unclear when allocation occurred.
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	Quote: "independent observers" Comment: unclear if observers were blinded to the procedure performed though the observers had not been involved in the surgery or care of the patient.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: Of 43 patients enrolled in the study, 12 were not included in final assessment (break down of reasons and which group participants were supplied). Of the bilateral hands, only the thumb operated on first was used for statistical analysis.
Selective reporting (reporting bias)	Unclear risk	Comment: We did not identify a protocol.