NCT04960722

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

A Randomized, Evaluator-blinded, Controlled Study to Evaluate the Safety and Clinical Performance of OIF/β-TCP in Patients With Open Tibial Fractures in Need of Bone Grafting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: BioGend Therapeutics Co.Ltd · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tibia Fracture

Interventions

Type	Name	Description
DEVICE	OIF/β-TCP	bone graft implantation

Timeline

• Start date: 2022-01-11
• Primary completion: 2024-09-24
• Completion: 2025-02-25
• First posted: 2021-07-14
• Last updated: 2025-09-24

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study