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. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4
Methods RCT
Exp: Trapeziectomy with LRTI
C: Trapeziectomy alone.
Participants Age (mean): Exp/C = 61/60
Gender (female/male): Exp/C = 46/9:51/8
Stage of OA (number of subjects): Exp/C = not reported, however 10 patients in the experiment and 9 patients in the control group had scaphotrapeziotrapezoid joint osteoarthritis
Interventions Exp: Trapeziectomy with LRTI (FCR). K‐wire to suspend thumb metacarpal for 4 weeks. Postoperatively a Plaster of Paris thumb spica splint was worn and then removed at 4 weeks. A thermoplastic splint was then worn for another 2 weeks with the thumb adducted.
C: Trapeziectomy. Postoperative immobilisation with bulky crepe bandage leaving the fingers free and removed after 3 to 4 weeks and replaced with a night splint.
Outcomes Pain: The number of subjects who reported 'no pain or restrictions; discomfort with use, but no restrictions; pain with use, some restrictions; rest pain, no restrictions; rest pain, some restrictions; rest pain, severe restrictions; night pain' were recorded for each group
Physical function: DASH Score
Patient global assessment: Patient Evaluation Measure
Range of motion: Radial and palmar abduction; opposition; thumb metacarpophalangeal extension;
Strength: Grip, key (lateral) pinch and tip pinch strength was measured with the same calibrated dynamometer or pinch meter and was measured in kg
Adverse events at 3 months, 1 year and 6 years: Numbness/tingling/tenderness in the innervation area of radial nerve or the palmar cutaneous branch of the median nerve, FCR pulling, De Quervain's disease, scar tenderness and chronic regional pain syndrome.
Notes We contacted the senior author (Davis) who confirmed this study used the same cohort of patients as the Davis 2009 study. One review author (TV) converted 95% CIs into SDs.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "three of each procedure was performed for every 6 patients" (Davis 2009) and "patients who had already been recruited into this study for surgery for the contralateral thumb had the alternative procedure performed on the contralateral side"
Comment: Unclear how the sequence was generated. Opposite procedure was performed on the contralateral hand of some patients.
Allocation concealment (selection bias) Unclear risk Quote: "A stratified sealed‐envelope technique was used for patients who contralateral thumb had not already been entered into this study".
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 Low risk Comment: A trainee surgeon followed up the patients at the 6‐year review mark reducing the risk of bias.
Incomplete outcome data (attrition bias) All outcomes Low risk Twelve patients (15 operations) were not reviewed at 6 years from a total of 111 patients (131 operations)
Comment: Unclear how many patients from each group were not‐followed up and for what reason (e.g. 3 patients died in both the T and T+LRTI group) however there were low attrition rates
Selective reporting (reporting bias) Unclear risk Comment: We did not identify a protocol.