Pilot Study in South Africa

Overview

A double-arm, randomized controlled clinical study was completed on the use of REPAIR™ Putty to treat open tibia fractures (trauma). The primary objective was to evaluate the safety and performance of the REPAIR Putty 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 REPAIR Putty; 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

Type of Injuries Putty Control P-Value
All Injuries 22.2% 80.0% 0.0048
IIIA and IIIB injuries 25.0% 100.0% 0.00024

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

% Wound Healed, 30 days

Type of Injuries Putty Control P-Value % Improvement
All Injuries 41.2 11.1 0.1276 3.7X Faster
IIIA and IIIB injuries 36.4% 0.0% 0.1078 Trending to Significance

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

Type of Injuries Putty Control P-Value
All Injuries 2.35 1.89 0.1769
IIIA and IIIB injuries 2.64 1.33 0.0445