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

A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

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

Study Overview

• Status: Completed
• Conditions: Foot Fusion
• Intervention / Treatment: Procedure: Standard of Care; Device: Augment® Bone Graft

• Study Type: Interventional
• Enrollment (Actual): 414
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Standard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft	Procedure: Standard of Care; Autologous Bone Graft
Experimental: Group 2; Standard Rigid Fixation plus Augment® Bone Graft	Device: Augment® Bone Graft; Augment® Bone Graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on Weight Bearing	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).; Clinically significant improvement: ≥20mm decrease from baseline; Detectable improvement: 10-20mm decrease from baseline; Maintained: <10mm decrease from baseline and <10mm increase from baseline; Deteriorated: >10mm increase from baseline	24 and 52 Weeks
Pain at Fusion Site	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).; Clinically significant improvement: ≥20mm decrease from baseline; Detectable improvement: 10-20mm decrease from baseline; Maintained: <10mm decrease from baseline and <10mm increase from baseline; Deteriorated: >10mm increase from baseline	24 and 52 weeks
Foot Function Index (FFI)	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.; Clinically significant improvement: ≥10 point decrease from baseline; Improved: 5-10 point decrease from baseline; Maintained: <5 point decrease from baseline and <5 point increase from baseline; Deteriorated: >5 point increase from baseline	24 and 52 weeks
AOFAS Hindfoot and Ankle Score	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.; Clinically significant improvement: ≥20 point increase from baseline; Improved: 10-20 point increase from baseline; Maintained: <10 point increase from baseline and <10 point decrease from baseline; Deteriorated: >10 point decrease from baseline	24 and 52 weeks
SF-12 Physical Component Score	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.; Maintenance or improvement: ≥0 point increase from baseline; Slight Decline: 0-10 point decrease from baseline; Deteriorated: >10 point decrease from baseline	24 and 52 weeks

Collaborators and Investigators

• Sponsor: BioMimetic Therapeutics
• Investigators: Principal Investigator: Christopher DiGiovanni, M.D., Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 20, 2007
• First Posted (Estimate): December 31, 2007

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: arthritis; ankle pain; foot pain; hindfoot fracture; ankle fracture
• Other Study ID Numbers: BMTI-2006-01