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NCT04960722
OIF/β-TCP in Patients With Open Tibial Fractures in Need of Bone Grafting
NA trial testing OIF/β-TCP in Tibia Fracture in 35 participants. Completed in 25 February 2025.
24 September 2024
Quick facts
| Lead sponsor | BioGend Therapeutics Co.Ltd |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 11 January 2022 |
| Primary completion | 24 September 2024 |
| Estimated completion | 25 February 2025 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- OIF/β-TCP
Conditions studied
- Tibia Fracture — all drugs for Tibia Fracture →
Sponsor
BioGend Therapeutics Co.Ltd
Who can join
21 and older, any sex, with Tibia Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04960722
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Tibia Fracture
Currently open trials in the same condition.
- NCT05859451 — Effect of Tobacco Heating System (THS) on Closed Lower Limb Fracture Healing · NA · recruiting
- NCT05151926 — Limb Injuries and Post Injury Rehabilitation Trials - Tibial Shaft Fracture · NA · recruiting
- NCT05668182 — A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects · recruiting
Other BioGend Therapeutics Co.Ltd trials
Trials by the same sponsor.
- NCT05924763 — The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04960722 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by BioGend Therapeutics Co.Ltd
- Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04960722.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing