Enhanced Bone Healing of Gustilo Iii Severe Open Tibia Fractures Treated by Immediate Antibiotic-Formulated Bone Grafting

Synthetic bone-substitute coated by polymer-lipid-encapsulation-matrix containing doxycycline (PLEX-DBG), constantly releasing antibiotics for one month, was used in a randomized, controlled study in 42 patients (out of 64 planned) with Gustilo IIIA, IIIB tibia fractures. Interim results in 12 patients treated with PLEX-DBG plus standard of care (SOC) versus 13 treated with SOC alone completing 4 months follow-up are presented. Time from surgery to the initiation of bone healing as assessed by the physicians (callus in 1 of 4 cortices) was reduced by approximately 33% in the PLEX-DBG group (95% confidence interval (CI) for 75% of the patients). Moreover, the study’s primary performance endpoint (PEP) time to “callus in 3 of 4 cortices”, was reduced by 32%, 75 days in PLEX-DBG group, versus 110 days in SOC group (95% CI for 50% of the patients). At 16 weeks’ time, more than 30% of the SOC patients did not achieve the PEP, versus 8% of PLEX-DBG patients. These results are consistent with the evaluation from the independent radiologists, where “callus in 3 of 4 cortices” was reduced by 28%, 82 days in the PLEX-DBG group, versus 114 days in SOC group (95% CI for 50% of the patients). In addition, pain-free weight bearing was demonstrated in 63% of the patients receiving PLEX-DBG plus SOC four months post-surgery, versus none of the patients (0%) receiving SOC alone. Conclusion: Immediate bone grafting with doxycycline formulated bone graft in sever open tibia fractures demonstrated early callus formation and reduction of pain on weight bearing.