Background and purpose The Artelon CMC spacer is designed for surgical treatment of osteoarthritis (OA) in the carpometacarpal joint of the thumb (CMC-I). Good results using this degradable device were previously presented in a pilot study. We now present results from a larger randomized, controlled, multicenter study. Patients and methods 109 patients (94 females) with a mean age of 60 (42-83) years, suffering from painful CMC OA, were included in the study at 7 centers in Sweden. The patients were randomized to Artelon CMC spacer (test, n = 72) or tendon arthroplasty (control, n = 37) at a ratio of 2:1. Perceived pain was recorded on a visual analog scale (VAS) before treatment and after 3, 6, and 12 months, when measuring maximal tripod pinch strength (primary outcome measure). In addition, range of motion, radiographic findings, and functional testing were recorded pre- and postoperatively. Results Swelling and pain were more common in the test group and 6 implants were removed because of such symptoms. 5 of these patients did not receive antibiotics preoperatively according to the study protocol. In a per-protocol analysis, i.e. patients without signs of concomitant OA in the scaphoid-trapezium-trapezoid (STT) joint and those in the test group who received antibiotics, the mean difference in tripod pinch strength increase, adjusted for baseline, was 1.4 kg in favor of the test group (not statistically significant). Statistically significant pain relief was achieved in both groups, with perceived pain gradually decreasing during the follow-up period. In the intention-to-treat analysis but not in the per-protocol analysis, significantly better pain relief (VAS) was obtained in the control group. Patient-perceived disability evaluated by the DASH questionnaire improved in both groups. Interpretation The Artelon CMC spacer did not show superior results compared to tendon interposition arthroplasty. Proper use of preoperative antibiotics and a thorough patient selection appear to be important for the results.
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