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Brief Title † | GEM OS™1 Bone Graft Compared to Autologous Bone Graft in Foot and Ankle Fusions | ||||
Official Title † | A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of GEM OS™1 Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions | ||||
Brief Summary | STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the "gold standard" (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: GEM OS™1 is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA) Application as a bone regeneration system, pivotal phase |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
Primary Outcome Measure † | Fusion Rate (%)(as determined by CT assessment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] | ||||
Secondary Outcome Measure † | Radiographic outcome assessments, Functional outcome measurements, clinical outcomes [ Time Frame: 24 and 36 weeks ] [ Designated as safety issue: No ] | ||||
Condition † | Foot Fusion | ||||
Intervention † | Device: GEM OS1 Procedure: Standard of Care |
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MEDLINE PMIDs | |||||
Links | Related Info ![]() Related Info  ![]() |
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Recruitment Information Fields | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | 396 | ||||
Start Date † | April 2007 | ||||
Completion Date | December 2009 | ||||
Eligibility Criteria † | Inclusion Criteria: 1) Bone defect in the hindfoot or ankle requiring fusion using open surgical technique with supplemental bone graft/substitute, requiring one of the following procedures:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Canada | ||||
Administrative Information Fields | |||||
NCT ID † | NCT00583375 | ||||
Organization ID | BMTI-2006-01 | ||||
Secondary IDs †† | |||||
Study Sponsor † | BioMimetic Therapeutics | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | BioMimetic Therapeutics | ||||
Verification Date | January 2009 | ||||
First Received Date † | December 20, 2007 | ||||
Last Updated Date | January 7, 2009 |