Clinical trial NCT00583375: Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Fusion
Keywords: arthritis
ankle pain
foot pain
hindfoot fracture
ankle fracture
Lead sponsor: BioMimetic Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-12-31
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Subjects Fused at 24 Weeks (as Determined by CT Assessment)
timeFrame: 24 weeks
Secondary outcomes:
measure: Pain on Weight Bearing
timeFrame: 24 and 52 Weeks
measure: Pain at Fusion Site
timeFrame: 24 and 52 weeks
measure: Foot Function Index (FFI)
timeFrame: 24 and 52 weeks
measure: AOFAS Hindfoot and Ankle Score
timeFrame: 24 and 52 weeks
measure: SF-12 Physical Component Score
timeFrame: 24 and 52 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: San Francisco
country: United States
facility: California Pacific Orthopaedics & Sports Medicine
state: California
city: Santa Cruz
country: United States
facility: Santa Cruz Orthopaedic Institute
state: California
city: Hartford
country: United States
facility: Hartford Hospital Orthopaedic Center
state: Connecticut
city: Royal Palm Beach
country: United States
facility: The Center for Bone & Joint Surgery
state: Florida
city: Savannah
country: United States
facility: Southern Orthopaedic Center
state: Georgia
city: Glenview
country: United States
facility: Illinois Bone and Joint Institute, Ltd.
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Wichita
country: United States
facility: Advanced Orthopaedic Associates
state: Kansas
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: East Lansing
country: United States
facility: Mid Michigan Orthopaedic Institute
state: Michigan
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Grand Rapids
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Hospital - West Bloomfield
state: Michigan
city: Las Vegas
country: United States
facility: Desert Orthopaedic Center
state: Nevada
city: Newark
country: United States
facility: UMDNJ
state: New Jersey
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Charlotte
country: United States
facility: Ortho Carolina Research Institute
state: North Carolina
city: Durham
country: United States
facility: Duke Health Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Orthopedic Foot & Ankle Center
state: Ohio
city: Bend
country: United States
facility: Orthopaedic & Neurosurgical Care & Research
state: Oregon
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Providence
country: United States
facility: University Orthopaedics, Inc
state: Rhode Island
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Bone and Joint Clinic of Houston
state: Texas
city: Arlington
country: United States
facility: The Orthopaedic Foot and Ankle Center
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Rhode Island Hospital
name: Christopher DiGiovanni, M.D.
role: PRINCIPAL_INVESTIGATOR
References: