Tibia Fracture
Conditions
Keywords
Bone graft
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.
Interventions
DEVICEOIF/β-TCP
bone graft implantation
Sponsors
BioGend Therapeutics Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\-
Exclusion criteria
1. Skeletally mature, male and female subjects who are \> 21 years old; 2. Females of non-childbearing potential or who have a negative result on pregnancy test within 72 hours prior to surgery, or males; 3. 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; 1. Gustilo type II with fracture gap at least 0.5 cm in length or severe damage to the periosteum after debridement or 2. 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; 4. Subjects with unilateral open tibial fractures; 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic (CT scan) Union at Week 30 | 30 weeks | Percentage of participants with complete fracture healing as assessed by CT scan at 30 weeks |
| Radiographic (X-Ray) Union at Week 30 | 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 | 30 weeks | Absence of any serious product-related AEs and lack of secondary intervention after bone grafting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Fracture Healing | 52 weeks | Patients is able to walk properly (Full weight bearing), no or mild pain (assessed by VAS score of 0-3) at the fracture site with full weight bearing and no fracture site tenderness on manual palpation |
| Radiographic-assessed bone healing | 52 weeks | Patients with complete bone healing, based on independent blinded central radiographic evaluations of the patient CT scans |
| Immunogenicity of OIF | 52 weeks | Percentage of subjects who were initially seronegative to OIF at baseline and exhibit authentic positive antibodies at Day 10, Week 6, Week 24 or Week 52 |
| Time from bone graft implantation to CT scan radiographic fracture healing | 52 weeks | The assessment of time from bone graft implantation to first X-ray radiographic fracture healing |
| Time from bone graft implantation to X-ray radiographic fracture healing | 52 weeks | The assessment of time from bone graft implantation to first X-ray radiographic fracture healing. |
Countries
Taiwan
Outcome results
None listed