Study Evaluating InductOs in Diaphyseal Tibia Fractures

Tibial Fractures Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161616
• Other study ID #: 3100N8-400
• Status: Completed
• Phase: Phase 4
• First received: September 7, 2005
• Last updated: July 31, 2009
• Start date: September 2003
• Est. completion date: August 2008

Study information

• Verified date: July 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Drug:
• InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Italy,  Netherlands,  Norway,  Poland,  Romania,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Healed Fractures		13 and 20 weeks	No
Secondary	Number of Patients Achieving Combined Clinical and Radiographic Endpoint (CCRE)		1 year	No