| 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. |