Study Evaluating InductOs in Diaphyseal Tibia Fractures

Phase 4

Completed

• Conditions: Tibial Fractures
• Interventions: Drug: InductOs

• Registration Number: NCT00161616
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2008-07
• Study Completion: 2008-08
• Status Verified: 2009-07
• Results First Submitted: 2009-07-31
• Results First Submitted QC: 2009-07-31
• Last Update Submitted: 2009-07-31
• Results First Posted: 2009-09-07
• Last Update Posted: 2009-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	InductOs	InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation
B	InductOs	Standard of Care: Surgical fixation only

Primary Outcome Measures

Name	Time	Method
Number of Patients With Healed Fractures	13 and 20 weeks	Patients categorized by investigator as healed, not healed, no outcome (using pre-specified criteria). Healed: no tenderness at fracture site or pain with weight bearing, presence of bridging callus or disappearance of fracture lines, no hardware failure, no secondary intervention to promote fracture healing. Not healed: diagnosis of delayed union or nonunion, hardware failure, secondary intervention procedure for fracture healing recommended or performed, or conduct of procedure that may interfere with fracture healing. No outcome: subjects who did not achieve either healed or not healed.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)	1 year	Patients categorized as Success or Failure of CCRE. Success defined as a fracture judged to be both clinically healed by clinical investigator, "healed" (see primary outcome), and radiographically united by independent, blinded radiology panel, "united." Patients deemed "not healed" or "not united" were assessed as failures.