CompletedNot Applicable

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

Taiwan35 participantsStarted 2022-01-11

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.

What they're measuring

Radiographic (CT scan) Union at Week 30

Timeframe: 30 weeks

Radiographic (X-Ray) Union at Week 30

Timeframe: 30 weeks

Incidence of Treatment-Emergent Adverse Events at Week 30

Timeframe: 30 weeks

Trial details

NCT IDNCT04960722

SponsorBioGend Therapeutics Co.Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-09-24

View on ClinicalTrials.gov More Tibia Fracture trials

Plain-language summary

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. 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.