ABOUT THIS STUDY
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- 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.
- 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.
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Descriptive Information | ||||||||||||||||||||||||||||||||||
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Brief Title ICMJE | Study Evaluating InductOs in Diaphyseal Tibia Fractures | |||||||||||||||||||||||||||||||||
Official Title ICMJE | A Prospective, Randomized, Controlled, Stratified Study of InductOs in Subjects With Open Diaphyseal Tibia Fractures Treated With Reamed Locked Intramedullary Nail Fixation | |||||||||||||||||||||||||||||||||
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 Provided | |||||||||||||||||||||||||||||||||
Study Type ICMJE | Interventional | |||||||||||||||||||||||||||||||||
Study Phase ICMJE | Phase 4 | |||||||||||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment | |||||||||||||||||||||||||||||||||
Condition ICMJE | Tibial Fractures | |||||||||||||||||||||||||||||||||
Intervention ICMJE | Drug: InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage | |||||||||||||||||||||||||||||||||
Study Arms ICMJE |
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Publications * | Not Provided | |||||||||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||||||||||||||||||||
Recruitment Information | ||||||||||||||||||||||||||||||||||
Recruitment Status ICMJE | Completed | |||||||||||||||||||||||||||||||||
Actual Enrollment ICMJE | 277 | |||||||||||||||||||||||||||||||||
Original Enrollment ICMJE | 300 | |||||||||||||||||||||||||||||||||
Actual Study Completion Date ICMJE | August 2008 | |||||||||||||||||||||||||||||||||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||||||||||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||||||||||||||||||||||||||||||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||||||||||||||
Listed Location Countries ICMJE | Belgium, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Romania, South Africa, Spain, United Kingdom | |||||||||||||||||||||||||||||||||
Removed Location Countries | ||||||||||||||||||||||||||||||||||
Administrative Information | ||||||||||||||||||||||||||||||||||
NCT Number ICMJE | NCT00161616 | |||||||||||||||||||||||||||||||||
Other Study ID Numbers ICMJE | 3100N8-400 | |||||||||||||||||||||||||||||||||
Has Data Monitoring Committee | No | |||||||||||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||||||||||||||
Responsible Party | Wyeth (Clinical Trial Registry Specialist), Wyeth | |||||||||||||||||||||||||||||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||||||||
Collaborators ICMJE | Not Provided | |||||||||||||||||||||||||||||||||
Investigators ICMJE |
| |||||||||||||||||||||||||||||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||||||||
Verification Date | July 2009 | |||||||||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |