Pilot Study in South Africa

Overview

A double-arm, randomized controlled clinical study was completed on the use of Bone Healing Accelerant to treat open tibia fractures (trauma). The primary objective was to evaluate the safety and performance of the Bone Healing Accelerant as an adjunct in the treatment of open tibia fractures.

A total of 20 treatment patients and 10 controls were enrolled at two hospitals in Cape Town, South Africa. Follow-up examinations, including X-ray and clinical assessments, occurred at 14, 30, 60, 90, 180, and 365 days. The primary endpoints of the study were safety and radiographic evidence of fracture healing; secondary endpoints included infections, wound closure, adverse events, pain, swelling and tenderness.

Safety

There were no adverse reactions to the use of the Bone Healing Accelerant; there was a reduction in adverse events observed with the use of the putty (47% < 80%, p = 0.0956).

Efficacy

There was a significant reduction of infections compared to controls, with more pronounced difference for the IIIA and IIIB injuries.

% Patients w 1+ Infections

Although it did not reach statistical significance, the Bone Healing Accelerant demonstrated a clear trend towards accelerated wound healing at 30 days, especially for the type IIIA and IIIB injuries.

% Wound Healed, 30 days

Bone healing was also accelerated compared to controls. The healing acceleration was especially evident for the more severe injuries (IIIA, IIIB).

Bone Healing - Mean Cortices Bridged, 180 days