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

This study has been completed.
Sponsor:
Information provided by:
BioMimetic Therapeutics
ClinicalTrials.gov Identifier:
NCT00583375
First received: December 20, 2007
Last updated: May 3, 2010
Last verified: May 2010
  Purpose

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 Intervention
Foot Fusion
Device: GEM OS1
Procedure: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by BioMimetic Therapeutics:

Primary Outcome Measures:
  • Fusion Rate (%)(as determined by CT assessment) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic outcome assessments, Functional outcome measurements, clinical outcomes [ Time Frame: 24 and 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 396
Study Start Date: April 2007
Study Completion Date: February 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583375

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

Additional Information:
No publications provided

Responsible Party: Russell P. Pagano, Ph.D, BioMimetic Therapeutics
ClinicalTrials.gov Identifier: NCT00583375     History of Changes
Other Study ID Numbers: BMTI-2006-01
Study First Received: December 20, 2007
Last Updated: May 3, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on April 17, 2014