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

Not Applicable

Completed

Conditions: Foot Fusion

Interventions: Device: Augment® Bone Graft
Procedure: Standard of Care

Registration Number: NCT00583375

Lead Sponsor: 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: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 414

Inclusion Criteria

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

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Augment® Bone Graft	Standard Rigid Fixation plus Augment® Bone Graft
Group 1	Standard of Care	Standard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft

Primary Outcome Measures

Name	Time	Method
Subjects Fused at 24 Weeks (as Determined by CT Assessment)	24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Pain on Weight Bearing	24 and 52 Weeks	Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). 1. Clinically significant improvement: ≥20mm decrease from baseline 2. Detectable improvement: 10-20mm decrease from baseline 3. Maintained: \<10mm decrease from baseline and \<10mm increase from baseline 4. Deteriorated: \>10mm increase from baseline
AOFAS Hindfoot and Ankle Score	24 and 52 weeks	Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes. 1. Clinically significant improvement: ≥20 point increase from baseline 2. Improved: 10-20 point increase from baseline 3. Maintained: \<10 point increase from baseline and \<10 point decrease from baseline 4. Deteriorated: \>10 point decrease from baseline
Pain at Fusion Site	24 and 52 weeks	Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). 1. Clinically significant improvement: ≥20mm decrease from baseline 2. Detectable improvement: 10-20mm decrease from baseline 3. Maintained: \<10mm decrease from baseline and \<10mm increase from baseline 4. Deteriorated: \>10mm increase from baseline
Foot Function Index (FFI)	24 and 52 weeks	The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment. 1. Clinically significant improvement: ≥10 point decrease from baseline 2. Improved: 5-10 point decrease from baseline 3. Maintained: \<5 point decrease from baseline and \<5 point increase from baseline 4. Deteriorated: \>5 point increase from baseline
SF-12 Physical Component Score	24 and 52 weeks	The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life. 1. Maintenance or improvement: ≥0 point increase from baseline 2. Slight Decline: 0-10 point decrease from baseline 3. Deteriorated: \>10 point decrease from baseline

Trial Locations

Locations (37): Southern Orthopaedic Center
🇺🇸
Savannah, Georgia, United States
Illinois Bone and Joint Institute, Ltd.
🇺🇸
Glenview, Illinois, United States
Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Orthopedic Foot & Ankle Center
🇺🇸
Columbus, Ohio, United States
Bone and Joint Clinic of Houston
🇺🇸
Houston, Texas, United States
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
University Health Network
🇨🇦
Toronto, Ontario, Canada
Desert Orthopaedic Center
🇺🇸
Las Vegas, Nevada, United States
California Pacific Orthopaedics & Sports Medicine
🇺🇸
San Francisco, California, United States
Duke Health Center
🇺🇸
Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Peter Lougheed Centre
🇨🇦
Calgary, Alberta, Canada
Queen Elizabeth II Health Sciences Center
🇨🇦
Halifax, Nova Scotia, Canada
Tucson Orthopaedic Institute
🇺🇸
Tucson, Arizona, United States
St. Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
Hartford Hospital Orthopaedic Center
🇺🇸
Hartford, Connecticut, United States
UMDNJ
🇺🇸
Newark, New Jersey, United States
Santa Cruz Orthopaedic Institute
🇺🇸
Santa Cruz, California, United States
The Center for Bone & Joint Surgery
🇺🇸
Royal Palm Beach, Florida, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Advanced Orthopaedic Associates
🇺🇸
Wichita, Kansas, United States
SIU School of Medicine
🇺🇸
Springfield, Illinois, United States
Henry Ford Hospital - West Bloomfield
🇺🇸
West Bloomfield, Michigan, United States
Orthopaedic Associates of Grand Rapids
🇺🇸
Grand Rapids, Michigan, United States
Mid Michigan Orthopaedic Institute
🇺🇸
East Lansing, Michigan, United States
Hospital for Special Surgery
🇺🇸
New York, New York, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
Orthopaedic & Neurosurgical Care & Research
🇺🇸
Bend, Oregon, United States
Campbell Clinic
🇺🇸
Germantown, Tennessee, United States
University Orthopaedics, Inc
🇺🇸
Providence, Rhode Island, United States
The Rothman Institute
🇺🇸
Philadelphia, Pennsylvania, United States
The Orthopaedic Foot and Ankle Center
🇺🇸
Arlington, Virginia, United States
Marshfield Clinic
🇺🇸
Marshfield, Wisconsin, United States
The Ottawa Hospital, General Campus
🇨🇦
Ottawa, Ontario, Canada
Ortho Carolina Research Institute
🇺🇸
Charlotte, North Carolina, United States