{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T17:43:24Z","timestamp":1792691004518,"version":"4.5.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T00:00:00Z","timestamp":1792627200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T00:00:00Z","timestamp":1792627200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Fibioseq Medical Ltd"},{"name":"Fibioseq Medical Ltd."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Arch Orthop Trauma Surg"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Total wrist arthroplasty (TWA) is limited by implant loosening, instability, and non-physiological load transfer, partly because most contemporary implants rely on a single center of rotation and do not preserve native wrist kinematics. This first-in-human pilot study evaluated the feasibility, early mechanical stability, and clinical outcomes of a novel bipolar dual-center TWA system designed to preserve radiocarpal and midcarpal motion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This prospective single-center pilot case series included five consecutive patients with end-stage wrist arthritis treated with a bipolar dual-center TWA implant using cement fixation, as per the device\u2019s intended use. The outcome measures included pain assessed using the pain subscale of the Patient-Rated Wrist Evaluation (PRWE) questionnaire (normalized to a 0\u201310 scale), total PRWE score, DASH score, range of motion, grip strength, radiographic implant stability, complications, and reoperation. Clinical outcomes were assessed at the most recent follow-up visit.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The mean follow-up was 19.2 months (range, 12\u201324 months), with 24-month data available for three patients. Implant survivorship was 100%, with no loosening, migration, dislocation, or implant revision observed on radiographs. One patient experienced a traumatic postoperative fall without loss of implant fixation. The mean PRWE-derived pain score improved from 9.0 to 3.0, and the mean PRWE total improved from 84.6 to 23.2 at the final follow-up. The mean DASH score improved from 79.0 to 29.5, with substantial inter-patient variability (final range, 0\u201391.7). All five patients met the predefined responder criterion of \u0394PRWE\u2009\u2265\u200920 combined with radiographic stability. Three patients with positive preoperative signs of carpal tunnel syndrome subsequently underwent carpal tunnel release 4\u20138 months postoperatively, with symptomatic improvement in all patients. One intraoperative carpal fracture was managed without component revision surgery. The mean wrist flexion improved from 13\u00b0 to 37\u00b0, and extension improved from 11\u00b0 to 32\u00b0.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This first-in-human pilot study demonstrated the technical feasibility and early mechanical stability of the bipolar dual-center TWA concept. All patients met the predefined wrist-specific responder criteria with stable mechanical implant fixation. These findings support further investigation of the dual-center concept in larger studies with longer follow-up periods.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00402-026-06493-z","type":"journal-article","created":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T17:25:30Z","timestamp":1792689930000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["First-in-human prospective pilot study of a bipolar dual-center total wrist arthroplasty: early mechanical stability and clinical outcomes"],"prefix":"10.1007","volume":"146","author":[{"given":"Raphael","family":"Israeli","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lauren","family":"Gorelick","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gil","family":"Gannot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amir","family":"Oron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,10,22]]},"reference":[{"key":"6493_CR1","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1177\/17531934241276383","volume":"50","author":"O Reigstad","year":"2025","unstructured":"Reigstad O (2025) Total wrist arthroplasty: recent advances and current recommendations. 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This affiliation represents a potential conflict of interest. The remaining authors declare that they have no conflicts of interest relevant to this article.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was approved by the Helsinki Committee (Institutional Review Board) of the hospital where the study was conducted (Approval No. KMC-0074-23). All study procedures were conducted in accordance with the Declaration of Helsinki.","order":2,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Written informed consent for participation in the study and publication of clinical data and accompanying images was obtained from all patients.","order":3,"name":"Ethics","label":"Patient consent","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"380"}}