Study Evaluating InductOs in Diaphyseal Tibia Fractures
NCT ID: NCT00161616
Last Updated: 2009-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
277 participants
INTERVENTIONAL
2003-09-30
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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A
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage +surgical fixation
InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
B
Standard of Care: Surgical fixation only
InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
Interventions
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InductOs
InductOs is rhBMP-2/ACS 1.5 mg/ml implanted once at the time of definitive fracture coverage
Eligibility Criteria
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Inclusion Criteria
* 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
* Presence of fracture distraction \> 2 mm following definitive fracture fixation.
* Presence of purulent drainage from the fracture site or evidence of active osteomyelitis.
18 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Ghent, , Belgium
Turku, , Finland
Créteil, , France
Toulouse, , France
Berlin, , Germany
Mainz, , Germany
Münster, , Germany
Pavia, , Italy
Roma, , Italy
Rotterdam, , Netherlands
Bergen, , Norway
Oslo, , Norway
Bialystok, , Poland
Lublin, , Poland
Sosnowiec, , Poland
Szczecin, , Poland
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bloemfontein, , South Africa
Cape Town, , South Africa
Cape Town, , South Africa
Centurion, , South Africa
Durban, , South Africa
Alcalá, , Spain
Bristol, , United Kingdom
Norwich, , United Kingdom
Countries
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Other Identifiers
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3100N8-400
Identifier Type: -
Identifier Source: org_study_id
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