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. 2015 Feb 23;2015(2):CD004631. doi: 10.1002/14651858.CD004631.pub4
Methods Controlled, prospective pilot study Exp A: Artelon TMC Spacer anchored with osteosutures Exp B: Artelon TMC Spacer anchored with titanium screws C: Trapeziectomy with tendon interposition (APL)
Participants Age (mean): Exp/C = 56/62 Gender (female/male): Exp/C = 9/1:5/0 Stage of OA (number of subjects): Exp/C = not reported, although all patients had isolated trapeziometacarpal osteoarthritis
Interventions Surgery Exp/C: Exp A: Artelon TMC Spacer anchored to bone with osteosutures Exp B: Artelon TMC Spacer anchored with titanium screws C: Trapeziectomy with APL arthroplasty. Postoperative = thumb immobilised in spica cast for 5 weeks
Outcomes Pain: VAS was used, with 0 representing no pain, 10 maximum pain. Note, measurements were recorded at maximum loading during key pinch Physical function: Sollerman Hand Function test was performed Patient global assessment: Likert scale of patients' subjective assessment of the treatment result at 3 year follow‐up Range of motion: radial and palmar abduction was measured in degrees with a goniometer Strength: grip strength was measured with a Jamar dynamometer, key and tripod pinch measured with a pinch gauge (North Coast Medical, Inc) Trapeziometacarpal joint imaging was performed to identify dislocation or adverse host tissue response Adverse events of local swelling and tenderness were reported at 2 weeks after surgery
Notes We attempted to contact one of the trial authors. No further information was provided One review author (EC) converted median into mean and SD values Acknowledgements: The Artelon manufacturer funded the trial
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Comment: Controlled, prospective pilot study (no randomisation).
Allocation concealment (selection bias) High risk
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Comment: Unclear if participants 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 Quote: "Indepdent observer who did not know which treatment group the patient had received examined all patients at the 3‐year follow‐up"
Incomplete outcome data (attrition bias) All outcomes Low risk Comment: One (APL) patient was followed up for 2 years, but not available for 3‐year review. Reason provided.
Selective reporting (reporting bias) High risk Comment: No protocol identified. Sollerman hand score listed in methods but no reported in results.