{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T01:28:19Z","timestamp":1777512499137,"version":"3.51.4"},"reference-count":50,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T00:00:00Z","timestamp":1711497600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T00:00:00Z","timestamp":1711497600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Trapeziometacarpal (TMC) osteoarthritis (OA) is a common cause of pain and weakness during thumb pinch leading to disability. There is no consensus about the best surgical treatment in unresponsive cases. The treatment is associated with costs and the recovery may take up to 1\u00a0year after surgery depending on the procedure. No randomized controlled trials have been conducted comparing ball and socket TMC prosthesis to trapeziectomy with ligament reconstruction.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A randomized, blinded, parallel-group superiority clinical trial comparing trapeziectomy with abductor pollicis longus (APL) arthroplasty and prosthetic replacement with Ma\u00efa\u00ae prosthesis. Patients, 18\u00a0years old and older, with a clinical diagnosis of unilateral or bilateral TMC OA who fulfill the trial\u2019s eligibility criteria will be invited to participate. The diagnosis will be made by experienced hand surgeons based on symptoms, clinical history, physical examination, and complementary imaging tests.<\/jats:p>\n                <jats:p>A total of 106 patients who provide informed consent will be randomly assigned to treatment with APL arthroplasty and prosthetic replacement with Ma\u00efa\u00ae prosthesis. The participants will complete different questionnaires including EuroQuol 5D-5L (EQ-5D-5L), the Quick DASH, and the Patient Rated Wrist Evaluation (PRWE) at baseline, at 6\u00a0weeks, and 3, 6, 12, 24, 36, 48, and 60\u00a0months after surgical treatment. The participants will undergo physical examination, range of motion assessment, and strength measure every appointment. The trial\u2019s primary outcome variable is the change in the visual analog scale (VAS) from baseline to 12\u00a0months. A long-term follow-up analysis will be performed every year for 5\u00a0years to assess chronic changes and prosthesis survival rate. The costs will be calculated from the provider\u2019s and society perspective using direct and indirect medical costs.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This is the first randomized study that investigates the effectiveness and cost-utility of trapeziectomy and ligament reconstruction arthroplasty and Ma\u00efa prosthesis. We expect the findings from this trial to lead to new insights into the surgical approach to TMC OA.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov NCT04562753. Registered on June 15, 2020.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08057-1","type":"journal-article","created":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T03:02:02Z","timestamp":1711508522000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1303-8158","authenticated-orcid":false,"given":"Seraf\u00edn","family":"Lirola-Palmero","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guillem","family":"Salva-Coll","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aina Mar\u00eda","family":"Y\u00e1\u00f1ez-Juan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eduardo","family":"S\u00e1nchez-Iriso","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,3,27]]},"reference":[{"issue":"9","key":"8057_CR1","doi-asserted-by":"publisher","first-page":"1581","DOI":"10.1136\/ard.2011.150078","volume":"70","author":"IK Haugen","year":"2011","unstructured":"Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, et al. 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