Efficacy and Safety Assessment of a Self-Setting Bone Substitute (α-TCP) as an Efficient Alternative to Autografts

Introduction: The objective of this pilot study was to assess the efficacy for bone healing and safety of a synthetic and innovative self-setting bone substitute compared with autografts.

Materials and Methods: All arthrodesis were performed by five surgeons during 2020 using a novel bone substitute (BIOCERA - VET, by TheraVet) to fill the gaps. Radiological and safety assessments were performed by the surgeons at each follow-up visits. Historical cases from 2015 to 2019 of tarsal and carpal arthrodesis performed with autograft to fill the gaps were used as control. A blinded radiological analysis was performed by an independent surgeon retrospectively evaluating the radiographs at 3 to 4 weeks and 6 to 8 weeks post-operatively.

Results: In total, 13 animals were treated with BIOCERA-VET, and 16 with autografts. 0/13 animals developed an infection compared with 3/16, respectively for BIOCERA-VET and autograft groups. Mean scores of 1.7 (SD ± 0.48) and 1.41 (SD ± 0.62) were obtained from the radiological analysis at 3 to 4 weeks follow-up and 2.08 (SD ± 0,64) and 1.87 (SD ± 0.62) at 6 to 8 weeks follow-up, respectively for BIOCERA-VET and autograft groups. No statistical difference was observed between these scores.

Discussion/Conclusion: The self-setting bone substitute has a comparable efficacy in terms of bone healing and remodelling process than autografts. However, a lower prevalence of complications was reported when the bone substitute was implemented. These first Results demonstrate that the use of BIOCERA-VET is an efficient and safe alternative to autografts, with an estimated lower risk of adverse events and decreased surgical time.

Acknowledgement: For the cases collection, BIOCERA-VET Bone Surgery, not being marketed, was provided free of charge by the company TheraVet.

Publication History

Article published online:
26 October 2022