Foot Fusion Clinical Trial
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
| Verified date | March 2018 |
| Source | BioMimetic Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 414 |
| Est. completion date | February 2010 |
| Est. primary completion date | January 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Peter Lougheed Centre | Calgary | Alberta |
| Canada | Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia |
| Canada | The Ottawa Hospital, General Campus | Ottawa | Ontario |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | University Health Network | Toronto | Ontario |
| Canada | St. Paul's Hospital | Vancouver | British Columbia |
| United States | The Orthopaedic Foot and Ankle Center | Arlington | Virginia |
| United States | Union Memorial Hospital | Baltimore | Maryland |
| United States | Orthopaedic & Neurosurgical Care & Research | Bend | Oregon |
| United States | Ortho Carolina Research Institute | Charlotte | North Carolina |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Orthopedic Foot & Ankle Center | Columbus | Ohio |
| United States | Duke Health Center | Durham | North Carolina |
| United States | Mid Michigan Orthopaedic Institute | East Lansing | Michigan |
| United States | Campbell Clinic | Germantown | Tennessee |
| United States | Illinois Bone and Joint Institute, Ltd. | Glenview | Illinois |
| United States | Orthopaedic Associates of Grand Rapids | Grand Rapids | Michigan |
| United States | Hartford Hospital Orthopaedic Center | Hartford | Connecticut |
| United States | Bone and Joint Clinic of Houston | Houston | Texas |
| United States | Desert Orthopaedic Center | Las Vegas | Nevada |
| United States | Marshfield Clinic | Marshfield | Wisconsin |
| United States | Loyola University Medical Center | Maywood | Illinois |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Columbia University Medical Center | New York | New York |
| United States | Hospital for Special Surgery | New York | New York |
| United States | UMDNJ | Newark | New Jersey |
| United States | The Rothman Institute | Philadelphia | Pennsylvania |
| United States | University Orthopaedics, Inc | Providence | Rhode Island |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | The Center for Bone & Joint Surgery | Royal Palm Beach | Florida |
| United States | California Pacific Orthopaedics & Sports Medicine | San Francisco | California |
| United States | Santa Cruz Orthopaedic Institute | Santa Cruz | California |
| United States | Southern Orthopaedic Center | Savannah | Georgia |
| United States | SIU School of Medicine | Springfield | Illinois |
| United States | Tucson Orthopaedic Institute | Tucson | Arizona |
| United States | Henry Ford Hospital - West Bloomfield | West Bloomfield | Michigan |
| United States | Advanced Orthopaedic Associates | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| BioMimetic Therapeutics |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |