Study Evaluating InductOs in Diaphyseal Tibia Fractures

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

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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