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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014