Clinical Studies
LongBone Clinical Study (GB-02-18)
This international clinical study was conducted to test the safety and effectiveness of a new bone substitute called b.Bone for treating bone defects in the leg (femur and tibia) and arm (humerus and forearm).
The study included 16 patients (4 women and 12 men) who mainly needed bone defect repair because their previous fractures didn’t heal properly. A complete follow-up up to 12 months was achieved in 11 out of the 16 patients.
The main goal was to check if b.Bone is safe to use. Other goals included seeing how well the bones healed, how much pain the patients felt, how well they could function, and their quality of life up to a year after surgery.
After 12 months, the average bone healing rate was 75%. Specifically, 7 patients (63.6%) had clear signs of bone healing, 3 patients (27.3%) showed possible healing, and 1 patient (9.1%) did not heal. Patients’ physical functioning, energy levels, emotional well-being, and social activities improved after a year compared to before surgery. b.Bone was found to be safe as there were no serious side effects related to the device and no minor side effects directly linked to it.
Overall, the results from the 16 patients showed that b.Bone is easy to use and effective for managing large bone defects, with high rates of bone healing and an excellent safety record.