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

  Hide Study Locations
Locations
United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
United States, California
California Pacific Orthopaedics & Sports Medicine
San Francisco, California, United States, 94118
Santa Cruz Orthopaedic Institute
Santa Cruz, California, United States, 95065
United States, Connecticut
Hartford Hospital Orthopaedic Center
Hartford, Connecticut, United States, 06106
United States, Florida
The Center for Bone & Joint Surgery
Royal Palm Beach, Florida, United States, 33411
United States, Georgia
Southern Orthopaedic Center
Savannah, Georgia, United States, 31405
United States, Illinois
Illinois Bone and Joint Institute, Ltd.
Glenview, Illinois, United States, 60025
Loyola University Medical Center
Maywood, Illinois, United States, 60153
SIU School of Medicine
Springfield, Illinois, United States, 62794
United States, Kansas
Advanced Orthopaedic Associates
Wichita, Kansas, United States, 67226
United States, Maryland
Union Memorial Hospital
Baltimore, Maryland, United States, 21218
United States, Michigan
Mid Michigan Orthopaedic Institute
East Lansing, Michigan, United States, 48823
Orthopaedic Associates of Grand Rapids
Grand Rapids, Michigan, United States, 49525
Henry Ford Hospital - West Bloomfield
West Bloomfield, Michigan, United States, 48322
United States, Nevada
Desert Orthopaedic Center
Las Vegas, Nevada, United States, 89121
United States, New Jersey
UMDNJ
Newark, New Jersey, United States, 07103
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Hospital for Special Surgery
New York, New York, United States, 10021
University of Rochester Medical Center
Rochester, New York, United States, 14627
United States, North Carolina
Ortho Carolina Research Institute
Charlotte, North Carolina, United States, 28209
Duke Health Center
Durham, North Carolina, United States, 27704
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Orthopedic Foot & Ankle Center
Columbus, Ohio, United States, 43231
United States, Oregon
Orthopaedic & Neurosurgical Care & Research
Bend, Oregon, United States, 97701
United States, Pennsylvania
The Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
University Orthopaedics, Inc
Providence, Rhode Island, United States, 02905
United States, Tennessee
Campbell Clinic
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Bone and Joint Clinic of Houston
Houston, Texas, United States, 77030
United States, Virginia
The Orthopaedic Foot and Ankle Center
Arlington, Virginia, United States, 22206
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Canada, Alberta
Peter Lougheed Centre
Calgary, Alberta, Canada, T1Y 6H6
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H 8L6
University Health Network
Toronto, Ontario, Canada, M5T 2S8
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 1R6
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 August 28, 2014