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GEM OS™1 Bone Graft Compared to Autologous Bone Graft in Foot and Ankle Fusions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583375
First Posted: December 31, 2007
Last Update Posted: May 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BioMimetic Therapeutics
December 20, 2007
December 31, 2007
May 4, 2010
April 2007
January 2010   (Final data collection date for primary outcome measure)
Fusion Rate (%)(as determined by CT assessment) [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT00583375 on ClinicalTrials.gov Archive Site
Radiographic outcome assessments, Functional outcome measurements, clinical outcomes [ Time Frame: 24 and 36 weeks ]
Same as current
Not Provided
Not Provided
 
GEM OS™1 Bone Graft Compared to Autologous Bone Graft in Foot and Ankle Fusions
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

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Foot Fusion
  • Device: GEM OS1
    GEM OS1 with sodium acetate buffer containing rhPDGF-BB
  • Procedure: Standard of Care
    Autologous Bone Graft
  • Active Comparator: Group 1
    Standard Rigid Fixation plus autograft
    Intervention: Procedure: Standard of Care
  • Experimental: Group 2
    Standard Rigid Fixation plus GEM OS1
    Intervention: Device: GEM OS1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
396
February 2010
January 2010   (Final data collection date for primary outcome measure)

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:

  • Ankle joint fusion
  • Subtalar fusion
  • Calcaneocuboid fusion
  • Talonavicular fusion
  • Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints)
  • Double fusions (talonavicular and calcaneocuboid joints)

Exclusion Criteria:

  1. Previous fusion surgery of the proposed fusion site.
  2. The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day).
  3. Pregnant or a female intending to become pregnant during this study period.
  4. Morbidly obese (BMI > 45 kg/m2)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00583375
BMTI-2006-01
Yes
Not Provided
Not Provided
Russell P. Pagano, Ph.D, BioMimetic Therapeutics
BioMimetic Therapeutics
Not Provided
Principal Investigator: Christopher DiGiovanni, M.D. Rhode Island Hospital
BioMimetic Therapeutics
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP