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

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.
ClinicalTrials.gov Identifier: NCT00583375
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : May 4, 2010
Information provided by:
BioMimetic Therapeutics

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

Condition or disease Intervention/treatment
Foot Fusion Device: GEM OS1 Procedure: Standard of Care

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Primary Completion Date : January 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group 1
Standard Rigid Fixation plus autograft
Procedure: Standard of Care
Autologous Bone Graft
Experimental: Group 2
Standard Rigid Fixation plus GEM OS1
Device: GEM OS1
GEM OS1 with sodium acetate buffer containing rhPDGF-BB

Primary Outcome Measures :
  1. Fusion Rate (%)(as determined by CT assessment) [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Radiographic outcome assessments, Functional outcome measurements, clinical outcomes [ Time Frame: 24 and 36 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583375

  Show 37 Study Locations
Sponsors and Collaborators
BioMimetic Therapeutics
Principal Investigator: Christopher DiGiovanni, M.D. Rhode Island Hospital

Additional Information:
Responsible Party: Russell P. Pagano, Ph.D, BioMimetic Therapeutics
ClinicalTrials.gov Identifier: NCT00583375     History of Changes
Other Study ID Numbers: BMTI-2006-01
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: May 2010

Keywords provided by BioMimetic Therapeutics:
ankle pain
foot pain
hindfoot fracture
ankle fracture