Tibia FractureNCT04960722

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

A study testing OIF/β-TCP in people with Tibia Fracture, run by BioGend Therapeutics Co.Ltd at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Tibia Fracture
What is being tested?: OIF/β-TCP
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteTaiwan
Study dates: 11 Jan 2022to 25 Feb 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Who cannot join

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;

Show all 29Show fewer

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.
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.
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;
Any autoimmune disease (e.g. Systemic Lupus Erythematosus or dermatomyositis);
Subjects with major psychiatric disorders, defining such disorders using standard criteria such as the DSM-V
Subjects with Insulin-dependent Diabetes mellitus.
Subjects with substance and alcohol abuse;
Current smokers* (*CDC: An adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.);
Previous exposure to rhBMP-2;
Hypersensitivity to protein pharmaceuticals, e.g, monoclonal antibodies, gamma globulins, and tricalcium phosphate;
History of hypersensitivity or allergy to kanamycin or aminoglycosides.
Treatment with any investigational therapy within 28 days of implantation surgery;
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);
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.
Individuals who have undergone a bone marrow transplant for the treatment of another condition;
Any condition that is not suitable to participate in the study based on the physician's judgement

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

BioGend Therapeutics
Taipei

Other trials in Taiwan

About this study

Official title: 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.

Read the detailed description

Study Objectives:

Primary objectives
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
Being tested: OIF/β-TCP
Keywords: Bone graft
Medical subject headings: Tibial Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OIF/β-TCPDevice
Also called BiG001
bone graft implantation

Study groups in NCT04960722
Study group	Role	What they receive
Control	Active comparator	autogenous bone graft Receives: Device: OIF/β-TCP
1.5 mg/g OIF/β-TCP	Experimental	1.5 mg/g OIF/β-TCP Receives: Device: OIF/β-TCP
2 mg/g OIF/β-TCP	Experimental	2 mg/g OIF/β-TCP Receives: Device: OIF/β-TCP
3 mg/g OIF/β-TCP	Experimental	3 mg/g OIF/β-TCP Receives: Device: OIF/β-TCP

What is being measured

The primary outcome is the main question the study is designed to answer.

Radiographic (CT scan) Union at Week 30
Percentage of participants with complete fracture healing as assessed by CT scan at 30 weeks
Measured: 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
Measured: 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
Measured: 30 weeks

Secondary outcomes (5)

Radiographic-assessed bone healing
Patients with complete bone healing, based on independent blinded central radiographic evaluations of the patient CT scans
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jan 202225 Feb 2025

First posted14 Jul 2021
Study start11 Jan 2022
Primary completion24 Sep 2024
Study completion25 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tibia FractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04960722
Sponsor's protocol ID: BiG001A102
Status last verified: Sep 2025
First submitted: 10 Jun 2021
Last updated: 24 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture

All Tibia Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04960722
Acronym / sponsor ID: BiG001A102
Conditions: Tibia Fracture
Keywords: Bone graft
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: BioGend Therapeutics Co.LtdIndustry (pharma, biotech, devices)
Study start: 11 Jan 2022 (actual)
Primary completion: 24 Sep 2024 (actual)
Study completion: 25 Feb 2025 (actual)
First posted: 14 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Objectives:

Primary objectives
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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Control	Active comparator	Device: OIF/β-TCPautogenous bone graft
1.5 mg/g OIF/β-TCP	Experimental	Device: OIF/β-TCP1.5 mg/g OIF/β-TCP
2 mg/g OIF/β-TCP	Experimental	Device: OIF/β-TCP2 mg/g OIF/β-TCP
3 mg/g OIF/β-TCP	Experimental	Device: OIF/β-TCP3 mg/g OIF/β-TCP

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Key exclusion criteria (29 listed)

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;
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OIF/β-TCPAlso: BiG001bone graft implantation	Device	1.5 mg/g OIF/β-TCP, 2 mg/g OIF/β-TCP, 3 mg/g OIF/β-TCP, Control

Primary outcome

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

5 secondary outcomes

Radiographic-assessed bone healing
Time frame: 52 weeks
Time from bone graft implantation to CT scan radiographic fracture healing
Time frame: 52 weeks
Time from bone graft implantation to X-ray radiographic fracture healing
Time frame: 52 weeks
Clinical Fracture Healing
Time frame: 52 weeks
Immunogenicity of OIF
Time frame: 52 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.

Related trials for Tibia Fracture

Not yet recruiting
Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures
Tibial Fracture, Femoral Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
RecruitingPhase 3
Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy
Open tíbia Fracture
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OIF/β-TCP in people with Tibia Fracture, run by BioGend Therapeutics Co.Ltd at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic (CT scan) Union at Week 30 (time frame: 30 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04960722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.