Augment® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

Not Applicable

Completed

Conditions: Congenital Deformity
Osteoarthritis
Arthritis
Degenerative Joint Disease
Rheumatoid Arthritis

Interventions: Procedure: Autologous bone graft
Device: Augment® Injectable Bone Graft

Registration Number: NCT01305356

Lead Sponsor: BioMimetic Therapeutics

Brief Summary: STUDY OBJECTIVES:

To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)

STUDY HYPOTHESIS:

Augment® Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness

STUDY RATIONALE:

To evaluate a fully synthetic bone graft material 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 Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft

Detailed Description: STUDY DESIGN:

Prospective, randomized, controlled, non-inferiority, multi-center trial

NUMBER OF STUDY CENTERS:

25

NUMBER OF SUBJECTS:

299 Subjects (see "Study Population"). The subject population included subjects enrolled in 3 separate Clinical Trials. (BMTI-2006-01, BMTI-2009-01, and BMTI-2010-01)

STUDY POPULATION:

Male and female subjects 18 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure.

TREATMENT GROUPS:

Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment® Injectable Bone Graft

Subjects will be randomized in a 2:1 ratio (Augment® Injectable:Autologous Bone Graft).

ROUTE OF ADMINISTRATION:

Investigational device is manually implanted inside and around the fusion space to ensure Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space

STUDY DURATION:

Twenty-four month follow-up post-surgery

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 299

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autologous bone graft	Autologous bone graft	Standard Rigid Fixation + Autologous bone graft
Augment® Injectable Bone Graft	Augment® Injectable Bone Graft	Standard rigid fixation + Augment® Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)

Primary Outcome Measures

Name	Time	Method
Pain on Weight Bearing	Baseline, 9, 12, 16, 24, 36, 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).

Secondary Outcome Measures

Name	Time	Method
AOFAS Hindfoot and Ankle Score	Baseline, 9, 12, 16, 24, 36, 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.
Fusion Site Pain	Baseline, 9, 12, 16, 24, 36, 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).
Foot Function Index (FFI)	Baseline, 9, 12, 16, 24, 36, 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 all ranging from 0-100. 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 and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment.
SF-12 Physical Component Score	Baseline, 9, 12, 16, 24, 36, 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.

Trial Locations

Locations (25): Union Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
University of Medicine & Dentistry of New Jersey
🇺🇸
Newark, New Jersey, United States
The Rothman Institute
🇺🇸
Philadelphia, Pennsylvania, United States
Texas Health Research & Education Institute
🇺🇸
Dallas, Texas, United States
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
St. Luke's Episcopal Hospital
🇺🇸
Houston, Texas, United States
St. Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
Life Mark Health Centre
🇨🇦
Calgary, Alberta, Canada
California Pacific Medical Center
🇺🇸
San Francisco, California, United States
Health Research Institute, Inc.
🇺🇸
Oklahoma City, Oklahoma, United States
Tucson Orthopaedic Research Center
🇺🇸
Tucson, Arizona, United States
University of Arizona
🇺🇸
Tucson, Arizona, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Mid Michigan Orthopaedic Institute
🇺🇸
East Lansing, Michigan, United States
Desert Orthopaedic Center
🇺🇸
Las Vegas, Nevada, United States
Illinois Bone & Joint Institute, Ltd.
🇺🇸
Glenview, Illinois, United States
Orthopaedic Associates of Michigan, PC
🇺🇸
Grand Rapids, Michigan, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
OrthoCarolina, PA
🇺🇸
Charlotte, North Carolina, United States
Hospital for Special Surgery
🇺🇸
New York, New York, United States
Cleveland Clinic Orthopaedic
🇺🇸
Cleveland, Ohio, United States
Orthopedic Foot & Ankle Center
🇺🇸
Columbus, Ohio, United States
Campbell Clinic / InMotion Orthopaedic Research Center
🇺🇸
Memphis, Tennessee, United States
Queen Elizabeth II Health Services
🇨🇦
Halifax, Nova Scotia, Canada
The Ottawa Hospital
🇨🇦
Ottawa, Ontario, Canada