Trial reportEuropean journal of orthopaedic surgery & traumatology : orthopedie traumatologie2026
Novel parathyroid hormone-based bone graft substitute, KUR-111, in treatment of tibial plateau fractures: a prospective, randomised, open-label, multicenter study.
Trial report in European journal of orthopaedic surgery & traumatology : orthopedie traumatologie, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundThe 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
methodsThe 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).
resultsA 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 (p = 0.03) 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 (0.4-0.9 mm) without significant differences (p > 0.10) 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.
conclusionKUR-111-high has the potential to be a promising adjunctive therapy in the treatment of closed TPFs. LEVEL OF EVIDENCE: Therapeutic Level I.
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