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

NCT04960722 | Completed FDA Device

• 1 other identifier: BiG001A102
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibia Fracture

Keywords

Bone graft

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Radiographic-assessed bone healing

  52 weeks

• Time from bone graft implantation to CT scan radiographic fracture healing

  52 weeks

• Time from bone graft implantation to X-ray radiographic fracture healing

  52 weeks

• Clinical Fracture Healing

  52 weeks

• Immunogenicity of OIF

  52 weeks

Study Arms (4)

Control

ACTIVE COMPARATOR

autogenous bone graft

Device: OIF/β-TCP

1.5 mg/g OIF/β-TCP

EXPERIMENTAL

1.5 mg/g OIF/β-TCP

Device: OIF/β-TCP

2 mg/g OIF/β-TCP

EXPERIMENTAL

2 mg/g OIF/β-TCP

Device: OIF/β-TCP

3 mg/g OIF/β-TCP

EXPERIMENTAL

3 mg/g OIF/β-TCP

Device: OIF/β-TCP

Interventions

OIF/β-TCP DEVICE

bone graft implantation

Also known as: BiG001

1.5 mg/g OIF/β-TCP; 2 mg/g OIF/β-TCP; 3 mg/g OIF/β-TCP; Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• Patients with a Glasgow Coma Scale less than 15 (less than fully awake) at the time of informed consent.
• Purulent drainage from the fracture, or evidence of active osteomyelitis;
• Compartment syndrome;
• Inadequate neovascular status;
• Pathological fractures; history of Paget's disease or other osteodystrophy; or history of heterotopic ossification;
• Endocrine or metabolic disorder that affects osteogenesis (e.g., hypo- or hyper-thyroidism or parathyroidism, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta)
• Has abnormal renal and/or hepatic functions, with Creatinine or ALT value \>5 times the upper normal limit;
• 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;

Sponsors & Collaborators

• BioGend Therapeutics Co.Ltd: lead

Study Sites (1)

BioGend Therapeutics

Taipei, Taiwan

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: July 14, 2021
• Study Start: January 11, 2022
• Primary Completion: September 24, 2024
• Study Completion: February 25, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

TW (1)