Clinical trial NCT02879149: Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
Official title: A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle and Hindfoot Arthrodesis
Keywords: Ankle Fusions
AUGMENT® Bone Graft
Autologous Bone Graft
arthritis
ankle pain
foot pain
hindfoot fracture
ankle fracture
Lead sponsor: BioMimetic Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-08-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects over the age of 18 years of age, who were randomized and treated as part of the population of the BMTI-2006-01 protocol.

Brief summary: The objective of this long-term study is to evaluate the long term effectiveness and safety of AUGMENT® Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under Protocol BMTI-2006-01.

Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2006-01.

STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.

REGULATORY PHASE: Post-approval study


Eligibility criteria: Inclusion Criteria:

Subjects who meet the following criteria may be included in the study:

1. Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
2. Must have been randomized, treated and included in the safety population of Protocol BMTI-2006-01 (see Exhibit 13.1).

Exclusion Criteria:

1) Subjects that were excluded from the safety analysis in the BMTI-2006-01 study (subjects not listed in Exhibit 13.1). These subjects were consented, but never treated as part of the BMTI-2006-01 protocol.

Primary outcomes:
measure: Demonstration of bridging bone via CT
timeFrame: Months 60 or greater
measure: Subject function as determined by pain on weight bearing
timeFrame: Months 60 or greater
measure: Subject function as determined by AOFAS - AHS score
timeFrame: Months 60 or greater
measure: Subject function as determined by Foot Function Index
timeFrame: Months 60 or greater
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopedic Institute
state: Arizona
city: Capitola
country: United States
facility: OrthoNorcal
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Royal Palm Beach
country: United States
facility: Center for Bone and Joint Surgery
state: Florida
city: Glenview
country: United States
facility: Illinois Bone and Joint Institute, LLC
state: Illinois
city: Baltimore
country: United States
facility: MedStar Health Research Institute/ Union Memorial Hospital
state: Maryland
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan, PC
state: Michigan
city: Lansing
country: United States
facility: Michigan Orthopedic Center
state: Michigan
city: Las Vegas
country: United States
facility: Desert Orthopaedics
state: Nevada
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Westerville
country: United States
facility: Orthopedic Foot and Ankle Center / OhioHealth Research Institute
state: Ohio
city: Bend
country: United States
facility: The Center
state: Oregon
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Falls Church
country: United States
facility: The Orthopaedic Foot & Ankle Center
state: Virginia
city: Calgary
country: Canada
facility: Office of Orthopaedic Surgeons, Talisman Centre North Building
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: QEll Health Sciences Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References: