ClinicalTrials.Veeva

Menu

Study Evaluating InductOs in Diaphyseal Tibia Fractures

Wyeth logo

Wyeth

Status and phase

Completed
Phase 4

Conditions

Tibial Fractures

Treatments

Drug: InductOs

Study type

Interventional

Funder types

Industry

Identifiers

NCT00161616
3100N8-400

Details and patient eligibility

About

Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.

Enrollment

277 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects with acute open tibial shaft fractures (Gustilo Type I, II, IIIA, or IIIB) who require surgical management with reamed, statically locked intramedullary nail fixation and who are at low risk for amputation.
  • Subjects should be at least 18 years of age, be skeletally mature, and be able to provide written informed consent.
  • Initial fracture stabilization and wound debridement should occur within 1 day after injury and DFC should occur within 14 days after injury.

Exclusion criteria

  • Planned treatment for the fracture should not include further procedures to promote fracture healing. After 16 weeks have elapsed since DFC, unanticipated procedures to promote fracture healing are permitted as clinically indicated.
  • Presence of fracture distraction > 2 mm following definitive fracture fixation.
  • Presence of purulent drainage from the fracture site or evidence of active osteomyelitis.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

277 participants in 2 patient groups

A
Active Comparator group
Description:
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation
Treatment:
Drug: InductOs
B
Other group
Description:
Standard of Care: Surgical fixation only
Treatment:
Drug: InductOs

Trial contacts and locations

27

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems