Phase 4 N=277 Randomized Single-blind Treatment

Study Evaluating InductOs in Diaphyseal Tibia Fractures

Tibial Fractures

Bottom Line

View on ClinicalTrials.gov: NCT00161616 ↗

Enrolled (actual)

277

Serious AEs

—

Results posted

Sep 2009

Primary outcome: Primary: Number of Patients With Healed Fractures — 83; 66; 8; 13 patients — p=0.0541

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: InductOs (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Healed Fractures	83; 66; 8; 13; 48; 59	0.0541
SECONDARY Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)	98; 96; 41; 42	0.8961

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00161616). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.