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

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.

Study Overview

• Status: Completed
• Conditions: Tibia Fracture
• Intervention / Treatment: Device: OIF/β-TCP

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • BioGend Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Exclusion Criteria:

Subjects will be excluded if ANY of the following exclusion criteria apply:

1. Patients with a Glasgow Coma Scale less than 15 (less than fully awake) at the time of informed consent.
2. Purulent drainage from the fracture, or evidence of active osteomyelitis;
3. Compartment syndrome;
4. Inadequate neovascular status;
5. Pathological fractures; history of Paget's disease or other osteodystrophy; or history of heterotopic ossification;
6. Endocrine or metabolic disorder that affects osteogenesis (e.g., hypo- or hyper-thyroidism or parathyroidism, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta)
7. Has abnormal renal and/or hepatic functions, with Creatinine or ALT value >5 times the upper normal limit;
8. History of malignancy, radiotherapy, or chemotherapy for any malignancy within the last 5 years. History of malignancy may include: Multiple exostoses syndrome ((also known as multiple osteochondromas syndrome), an inherited condition associated with bumps of cartilage on the bones, has been associated with an increased risk of chondrosarcoma), any cancer prone syndrome, such as Li-Fraumeni;
9. Any autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis);
10. Subjects with major psychiatric disorders, defining such disorders using standard criteria such as the DSM-V
11. Subjects with Insulin-dependent Diabetes mellitus.
12. Subjects with substance and alcohol abuse;
13. Current smokers* (*CDC: An adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.);
14. Previous exposure to rhBMP-2;
15. Hypersensitivity to protein pharmaceuticals, e.g, monoclonal antibodies, gamma globulins, and tricalcium phosphate;
16. History of hypersensitivity or allergy to kanamycin or aminoglycosides.
17. Treatment with any investigational therapy within 28 days of implantation surgery;
18. Treatment with prednisone for 7 days or more within previous 6 months (cumulative dose> 150 mg or other steroids with equivalent dose, refer to Appendix 2 in the protocol); calcitonin (within previous 6 months); bisphosphonates (for 30 days or more within previous 12 months); or therapeutic doses of fluoride (for 30 days within previous 12 months);
19. A female that is currently pregnant or breastfeeding at time of enrollment, or have plans to become pregnant with the next one year; or female subjects of childbearing potential and male subjects with partners of childbearing potential that do not agree to use protocol approved methods of contraception throughout the study.
20. Individuals who have undergone a bone marrow transplant for the treatment of another condition;
21. Any condition that is not suitable to participate in the study based on the physician's judgement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; autogenous bone graft	Device: OIF/β-TCP; bone graft implantation; Other Names: BiG001
Experimental: 1.5 mg/g OIF/β-TCP	Device: OIF/β-TCP; bone graft implantation; Other Names: BiG001
Experimental: 2 mg/g OIF/β-TCP	Device: OIF/β-TCP; bone graft implantation; Other Names: BiG001
Experimental: 3 mg/g OIF/β-TCP	Device: OIF/β-TCP; bone graft implantation; Other Names: BiG001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic (CT scan) Union at Week 30	Percentage of participants with complete fracture healing as assessed by CT scan at 30 weeks	30 weeks
Radiographic (X-Ray) Union at Week 30	Percentage of participants with bridging on three of four cortices assessed by X-Ray (RUST) at 30 weeks	30 weeks
Incidence of Treatment-Emergent Adverse Events at Week 30	Absence of any serious product-related AEs and lack of secondary intervention after bone grafting	30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic-assessed bone healing	Patients with complete bone healing, based on independent blinded central radiographic evaluations of the patient CT scans	52 weeks
Time from bone graft implantation to CT scan radiographic fracture healing	The assessment of time from bone graft implantation to first X-ray radiographic fracture healing	52 weeks
Time from bone graft implantation to X-ray radiographic fracture healing	The assessment of time from bone graft implantation to first X-ray radiographic fracture healing.	52 weeks
Clinical Fracture Healing	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	52 weeks
Immunogenicity of OIF	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	52 weeks

Collaborators and Investigators

• Sponsor: BioGend Therapeutics Co.Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Actual): September 24, 2024
• Study Completion (Actual): February 25, 2025

Study Registration Dates

• First Submitted: June 10, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 14, 2021

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Bone graft
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: BiG001A102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes