Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions

NCT00583375 | Completed Results DMC

• 1 other identifier: BMTI-2006-01
• Study Type: interventional
• Target: 414
• Locations: 2 countries
• Sites: 37

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: Augment® Bone Graft 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

Conditions

Foot Fusion

Keywords

arthritis; ankle pain; foot pain; hindfoot fracture; ankle fracture

Outcome Measures

Primary Outcomes (1)

• Subjects Fused at 24 Weeks (as Determined by CT Assessment)

  An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused.

  24 weeks

Secondary Outcomes (5)

• Pain on Weight Bearing

  24 and 52 Weeks

• Pain at Fusion Site

  24 and 52 weeks

• Foot Function Index (FFI)

  24 and 52 weeks

• AOFAS Hindfoot and Ankle Score

  24 and 52 weeks

• SF-12 Physical Component Score

  24 and 52 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Standard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft

Procedure: Standard of Care

Group 2

EXPERIMENTAL

Standard Rigid Fixation plus Augment® Bone Graft

Device: Augment® Bone Graft

Interventions

Augment® Bone Graft DEVICE

Augment® Bone Graft

Group 2

Standard of Care PROCEDURE

Autologous Bone Graft

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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)

You may not qualify if:

• Previous fusion surgery of the proposed fusion site.
• The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage \> 10mg/day).
• Pregnant or a female intending to become pregnant during this study period.
• Morbidly obese (BMI \> 45 kg/m2)

Sponsors & Collaborators

• BioMimetic Therapeutics: lead

Study Sites (37)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

California Pacific Orthopaedics & Sports Medicine

San Francisco, California, 94118, United States

Location

Santa Cruz Orthopaedic Institute

Santa Cruz, California, 95065, United States

Location

Hartford Hospital Orthopaedic Center

Hartford, Connecticut, 06106, United States

Location

The Center for Bone & Joint Surgery

Royal Palm Beach, Florida, 33411, United States

Location

Southern Orthopaedic Center

Savannah, Georgia, 31405, United States

Location

Illinois Bone and Joint Institute, Ltd.

Glenview, Illinois, 60025, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

SIU School of Medicine

Springfield, Illinois, 62794, United States

Location

Advanced Orthopaedic Associates

Wichita, Kansas, 67226, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Mid Michigan Orthopaedic Institute

East Lansing, Michigan, 48823, United States

Location

Orthopaedic Associates of Grand Rapids

Grand Rapids, Michigan, 49525, United States

Location

Henry Ford Hospital - West Bloomfield

West Bloomfield, Michigan, 48322, United States

Location

Desert Orthopaedic Center

Las Vegas, Nevada, 89121, United States

Location

UMDNJ

Newark, New Jersey, 07103, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14627, United States

Location

Ortho Carolina Research Institute

Charlotte, North Carolina, 28209, United States

Location

Duke Health Center

Durham, North Carolina, 27704, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Orthopedic Foot & Ankle Center

Columbus, Ohio, 43231, United States

Location

Orthopaedic & Neurosurgical Care & Research

Bend, Oregon, 97701, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

University Orthopaedics, Inc

Providence, Rhode Island, 02905, United States

Location

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Bone and Joint Clinic of Houston

Houston, Texas, 77030, United States

Location

The Orthopaedic Foot and Ankle Center

Arlington, Virginia, 22206, United States

Location

Marshfield Clinic

Marshfield, Wisconsin, 54449, United States

Location

Peter Lougheed Centre

Calgary, Alberta, T1Y 6H6, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 3A7, Canada

Location

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

University Health Network

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Arthritis; Ankle Fractures

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Stephen Roach
• Organization: Wright Medical

Stephen.Roach@wright.com

615-656-7466

Study Officials

• Christopher DiGiovanni, M.D.

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 2, 2018
• Results First Posted: February 23, 2018

Record last verified: 2018-03

Locations

CA (6); US (31)