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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tibia Fracture
- Sponsor
- BioGend Therapeutics Co.Ltd
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Radiographic (CT scan) Union at Week 30
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Skeletally mature, male and female subjects who are \> 21 years old;
- •Females of non-childbearing potential or who have a negative result on pregnancy test within 72 hours prior to surgery, or males;
- •Isolated open tibial fractures, which is classified as below and within 3 months of initial fracture, and soft tissue stable without any sign of active infection;
- •Gustilo type II with fracture gap at least 0.5 cm in length or severe damage to the periosteum after debridement or
- •Gustilo type IIIA with fracture gap at least 0.5 cm in length or IIIB with fracture gap at least 0.5 cm in length;
- •Subjects with unilateral open tibial fractures;
- •Willing to provide signed informed consent form (ICF) prior to participation in any study-related procedures and adhere to the study requirements for the length of the trial.
- •Exclusion Criteria:
- •Subjects will be excluded if ANY of the following exclusion criteria apply:
- •Patients with a Glasgow Coma Scale less than 15 (less than fully awake) at the time of informed consent.
Outcomes
Primary Outcomes
Radiographic (CT scan) Union at Week 30
Time Frame: 30 weeks
Percentage of participants with complete fracture healing as assessed by CT scan at 30 weeks
Radiographic (X-Ray) Union at Week 30
Time Frame: 30 weeks
Percentage of participants with bridging on three of four cortices assessed by X-Ray (RUST) at 30 weeks
Incidence of Treatment-Emergent Adverse Events at Week 30
Time Frame: 30 weeks
Absence of any serious product-related AEs and lack of secondary intervention after bone grafting
Secondary Outcomes
- Radiographic-assessed bone healing(52 weeks)
- Time from bone graft implantation to CT scan radiographic fracture healing(52 weeks)
- Immunogenicity of OIF(52 weeks)
- Time from bone graft implantation to X-ray radiographic fracture healing(52 weeks)
- Clinical Fracture Healing(52 weeks)