{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T15:14:30Z","timestamp":1768403670186,"version":"3.49.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T00:00:00Z","timestamp":1768348800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T00:00:00Z","timestamp":1768348800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Kuros Biosurgery AG"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Orthop Surg Traumatol"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      The treatment of closed tibial plateau fractures (TPF) is complex and carries a risk of malunion. Parathyroid hormone (PTH) plays a key role in bone metabolism, and a PTH-peptide (PTH\n                      <jats:sub>1\u2009\u2212\u200934<\/jats:sub>\n                      ) promotes bone healing. The objective was to evaluate the safety and efficacy of a novel PTH-based bone-graft-substitute (KUR-111) in the treatment of TPF.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study was a randomised, controlled, multicenter, open-label (dose-blinded), and dose-finding clinical trial. Subjects were randomised into 3 groups (iliac crest autograft (control); KUR-111-low; and high-dose TGplPTH1-34). The primary efficacy endpoint was the rate of union by computed tomography (CT) at 16weeks, as assessed by the Independent Radiologist Evaluation Panel (IREP).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 183 TPF were enrolled and treated. The primary endpoint was met, as statistical non-inferiority was demonstrated for KUR-111-high compared with autograft at 16weeks. KUR-111-high significantly (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.03) increased union rates compared to KUR-111-low (83.6%vs66.1%). IREP and a clinician-assessed composite score of fracture healing showed higher healing rates for KUR-111-high than KUR-111-low or autograft. Loss of reduction was minimal (0.4\u20130.9\u00a0mm) without significant differences (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&gt;\u20090.10) among groups. Mean pain of the treated knee improved from baseline, with the least pain for KUR-111-high at all timepoints. Clinically significant donor-site pain was reported by 61.8% at discharge and remained in 12.2% of subjects at 104weeks. By 104weeks, analgesic use following KUR-111-high was less than one-half (9.8%vs24.1%), and opioid use was approximately 7-fold lower (1.6%vs12.1%) as compared to autograft.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>KUR-111-high has the potential to be a promising adjunctive therapy in the treatment of closed TPFs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Level of evidence<\/jats:title>\n                    <jats:p>Therapeutic Level I.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00590-025-04645-2","type":"journal-article","created":{"date-parts":[[2026,1,14]],"date-time":"2026-01-14T09:17:37Z","timestamp":1768382257000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Novel parathyroid hormone-based bone graft substitute, KUR-111, in treatment of tibial plateau fractures: a prospective, randomised, open-label, multicenter study"],"prefix":"10.1007","volume":"36","author":[{"given":"Nikolaos K","family":"Kanakaris","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael J","family":"Raschke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joe M","family":"Lane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James T","family":"Ryaby","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brent L","family":"Atkinson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter V","family":"Giannoudis","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2026,1,14]]},"reference":[{"key":"4645_CR1","doi-asserted-by":"publisher","unstructured":"Bormann M, Neidlein C, Neidlein N, Ehrl D, Jorgens M, Berthold DP, Bocker W, Holzapfel BM, Furmetz J (2023) High prevalence of persistent measurable postoperative knee joint laxity in patients with tibial plateau fractures treated by open reduction and internal fixation (ORIF). 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