| Title: |
Safety and Efficacy of rhBMP-2 for Treating Acute Traumatic Fractures of the Upper and Lower Extremities: A Multicenter Prospective Study |
| Authors: |
Sakong, S; Hong, S; Choi, W; Kang, S; Cho, JW; Son, WS; Choi, JS; Yon, CJ; Cho, WT; Oh, JK |
| Contributors: |
115377; 113474; Sakong, S; Cho, WT |
| Publication Year: |
2026 |
| Subject Terms: |
bone morphogenetic protein-2; bone regeneration; fracture; hydroxyapatite; trauma |
| Description: |
Background: Delayed or non-union fractures comprise 5-10% of cases, indicating the need for biologic interventions. Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a potent osteoinductive agent; yet, collagen carrier-based uncontrolled release causes adverse events. We evaluated the safety and efficacy of a hydroxyapatite (HA) carrier-based rhBMP-2 delivery system for acute traumatic upper and lower fractures exhibiting bone defects. Methods: This prospective, multicenter, single-arm clinical trial enrolled 90 patients who underwent surgery using a hydroxyapatite (HA) carrier-based rhBMP-2 delivery system (Novosis(TM)). Radiographically validated union at 6 and 12 months post-surgery and treatment success (union without additional surgery) were used to assess efficacy. The incidence, type, and severity of all device-related adverse events during follow-up were monitored by investigators to evaluate safety. Results: Of the 90 patients enrolled, 81 were included in the full analysis set. The mean age was 58.5 years, and 18.6% (15/81) had open fractures. At 6 months post-surgery, radiographically validated union was achieved in 81.5% (66/81) of patients, increasing to 96.2% (77/81) at 12 months after surgery. Treatment success was 95.0% (76/81). Adverse events were rare (1/81, 1.2%). No ectopic ossification, systemic complications, or severe inflammatory responses were observed. Conclusions: HA-based rhBMP-2 intervention demonstrated favorable union rates and safety with minimal complications in acute upper and lower fractures with bone defects. The biocompatibility and controlled-release properties of HA likely improved efficacy and reduced complications. Results should be interpreted as feasibility data from a heterogeneous case series without a control group. Larger randomized controlled comparative trials are warranted for optimal dosing and evaluating efficacy and cost-effectiveness. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
J010139087; http://repository.ajou.ac.kr/handle/201003/34998; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12898693 |
| DOI: |
10.3390/jcm15031176 |
| Availability: |
http://repository.ajou.ac.kr/handle/201003/34998; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12898693; https://doi.org/10.3390/jcm15031176 |
| Accession Number: |
edsbas.ADC6D8E7 |
| Database: |
BASE |