In a study of 81 people with badly broken bones, surgeons packed a bone-growing protein into the gap instead of a bone graft. Nearly all of the fractures healed within a year.
This article covers emerging musculoskeletal and regenerative-medicine research. It reflects what may be coming in the field, not the treatments ADX or its network physicians currently provide.
Why It Matters
When a bone breaks so badly that a piece of it is missing, surgery alone may not be enough. Surgeons often have to take bone from somewhere else in the patient’s body to fill the hole, which means a second wound and more pain. Researchers are testing a bone-growing protein that can be packed into the gap instead. If it works, people with severe fractures could heal with one surgery rather than two.
The Study
A team of orthopedic trauma surgeons at five South Korean hospitals ran a prospective, multicenter trial of a bone graft substitute built around recombinant human bone morphogenetic protein-2, or rhBMP-2. rhBMP-2 is a signaling protein that tells the body’s own cells to build new bone. Earlier versions of the product delivered the protein on a collagen sponge, which released nearly all of it within 24 hours and was associated with swelling and bone forming where it did not belong. The device tested here (Novosis, CGBio) loads the protein onto a hydroxyapatite mineral carrier designed for slow release, retaining roughly 80 percent of the protein after the first week.
Between September 2022 and December 2024, the investigators enrolled 90 adults with acute upper- or lower-extremity fractures that required internal fixation and had a traumatic bone defect under 5 cm involving at least half the circumference of the shaft. Eighty-one patients formed the analysis population. Mean age was 58.5 years, 60.5 percent of injuries were in the upper extremity, 18.6 percent were open fractures, and 44.4 percent were the most severe AO/OTA Type C pattern. During open reduction and internal fixation, surgeons placed the rhBMP-2 device into the defect, with the dose scaled to defect size (mean 1.10 mg; 6 mg maximum). Healing was scored on plain radiographs by two fellowship-trained trauma surgeons blinded to each other’s reads, using a Radiographic Union Score for Tibial fractures threshold of 9 or higher, with a third reviewer settling disagreements.
Radiographic union was reached in 66 of 81 patients (81.5 percent) at six months and 77 of 81 (96.2 percent) at 12 months, the study’s primary endpoint. Treatment success, defined as union without any additional surgery, was 95.0 percent, and only two patients (2.5 percent) needed a second operation to get the fracture to heal. Safety findings were unremarkable: one mild seroma judged possibly device-related, no ectopic bone formation, no severe inflammatory reactions, and no systemic complications. Of the five patients whose treatment was not successful, three had open fractures.
The authors are careful about what this does and does not show. Because the trial was single-arm, there is no comparison group receiving an autologous bone graft or the mineral carrier alone, so the study cannot isolate how much of the healing is attributable to rhBMP-2 itself. The cohort mixed many fracture locations and patterns, the decision to use the device rested on each surgeon’s judgment of nonunion risk, and follow-up ran only 12 months, which the authors note is too short to rule out long-term risks. They describe their own results as feasibility data from a heterogeneous case series and call for a randomized controlled trial. Read that way, the finding is a promising signal that a slow-release bone-growing protein can support healing in high-risk fractures with few side effects, not yet evidence that it should replace a bone graft in routine care.
Source: Journal of Clinical Medicine, Sakong et al., 2026
Research compiled by ADX AI Agent, reviewed by Sean Gallivan