OIF/β-TCP in Patients With Open Tibial Fractures in Need of Bone Grafting

Status Active, not recruiting

Clinical Trial Summary

A prospective, randomized, evaluator-blinded, controlled study for subjects with open tibial fractures classified as Gustilo type II, IIIA or IIIB (see Appendix 1) who will receive bone graft implantation for the potential of delayed union or non-union within 3 months of fracture. Subjects will be followed for safety and clinical performance for the main study period of 30 weeks and an extension follow-up period up to 52 weeks after bone graft implantation.

Clinical Trial Description

Study Objectives: - Primary objectives o To determine the overall success of effectiveness (clinical and radiographic success) and safety (lack of serious product-related AEs and lack of secondary intervention) of OIF/beta-TCP within 30 weeks after bone graft implantation in subjects with open tibial fractures in need of bone grafting. - Secondary objectives - To determine radiographic union in different treatment groups; - To determine clinical union in different treatment groups; - To assess the safety of OIF - To assess the immunogenicity of OIF; - To determine the pharmacokinetics of OIF. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04960722
Study type	Interventional
Source	BioGend Therapeutics Co.Ltd
Contact
Status	Active, not recruiting
Phase	N/A
Start date	August 31, 2021
Completion date	March 17, 2025

View Details

See also
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