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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Standard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft |
|
| Group 2 | Experimental | Standard Rigid Fixation plus Augment® Bone Graft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augment® Bone Graft | Device | Augment® Bone Graft |
| |
| Standard of Care |
| 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 |
| 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).
|
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher DiGiovanni, M.D. | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States | ||
| California Pacific Orthopaedics & Sports Medicine |
17 subjects excluded post-operatively
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Standard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft |
| FG001 | Group 2 | Standard Rigid Fixation plus Augment® Bone Graft |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Procedure |
Autologous Bone Graft |
|
| 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).
| 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.
| 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.
| 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.
| 24 and 52 weeks |
| San Francisco |
| California |
| 94118 |
| United States |
| Santa Cruz Orthopaedic Institute | Santa Cruz | California | 95065 | United States |
| Hartford Hospital Orthopaedic Center | Hartford | Connecticut | 06106 | United States |
| The Center for Bone & Joint Surgery | Royal Palm Beach | Florida | 33411 | United States |
| Southern Orthopaedic Center | Savannah | Georgia | 31405 | United States |
| Illinois Bone and Joint Institute, Ltd. | Glenview | Illinois | 60025 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| SIU School of Medicine | Springfield | Illinois | 62794 | United States |
| Advanced Orthopaedic Associates | Wichita | Kansas | 67226 | United States |
| Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Mid Michigan Orthopaedic Institute | East Lansing | Michigan | 48823 | United States |
| Orthopaedic Associates of Grand Rapids | Grand Rapids | Michigan | 49525 | United States |
| Henry Ford Hospital - West Bloomfield | West Bloomfield | Michigan | 48322 | United States |
| Desert Orthopaedic Center | Las Vegas | Nevada | 89121 | United States |
| UMDNJ | Newark | New Jersey | 07103 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Rochester Medical Center | Rochester | New York | 14627 | United States |
| Ortho Carolina Research Institute | Charlotte | North Carolina | 28209 | United States |
| Duke Health Center | Durham | North Carolina | 27704 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Orthopedic Foot & Ankle Center | Columbus | Ohio | 43231 | United States |
| Orthopaedic & Neurosurgical Care & Research | Bend | Oregon | 97701 | United States |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | United States |
| University Orthopaedics, Inc | Providence | Rhode Island | 02905 | United States |
| Campbell Clinic | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Bone and Joint Clinic of Houston | Houston | Texas | 77030 | United States |
| The Orthopaedic Foot and Ankle Center | Arlington | Virginia | 22206 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| Peter Lougheed Centre | Calgary | Alberta | T1Y 6H6 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Queen Elizabeth II Health Sciences Center | Halifax | Nova Scotia | B3H 3A7 | Canada |
| The Ottawa Hospital, General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5C 1R6 | Canada |
| University Health Network | Toronto | Ontario | M5T 2S8 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
The safety population consisted of 414 patients, 272 randomized to Augment® Bone Graft and 142 randomized to autograft. The mITT population, submitted as the primary effectiveness analysis for the radiographic evaluation of bridging bone, consisted of 397 patients (414 patients in the Safety group minus 17 subjects excluded post-operatively).
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Standard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft |
| BG001 | Group 2 | Standard Rigid Fixation plus Augment® Bone Graft |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The mITT population consisted of 397 patients (414 patients in the Safety group minus 17 subjects excluded post-operatively). | Posted | Count of Participants | Participants | 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).
| Analysis conducted on patients at 24 and 52 weeks time points. | Posted | Count of Participants | Participants | 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).
| Analysis conducted on patients at 24 and 52 weeks time points. | Posted | Count of Participants | Participants | 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.
| Analysis conducted on patients at 24 and 52 weeks time points. | Posted | Count of Participants | Participants | 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.
| Analysis conducted on patients at 24 and 52 weeks time points. | Posted | Count of Participants | Participants | 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.
| Analysis conducted on patients at 24 and 52 weeks time points. | Posted | Count of Participants | Participants | 24 and 52 weeks |
|
|
Patients were assessed through study completion scheduled at 52 weeks following surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Standard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft | 0 | 142 | 21 | 142 | 43 | 142 |
| EG001 | Group 2 | Standard Rigid Fixation plus Augment® Bone Graft | 1 | 272 | 28 | 272 | 100 | 272 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Atrial flutter | Cardiac disorders | Systematic Assessment |
| ||
| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Congenital foot malformation | Congenital, familial and genetic disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Megacolon | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Impaired healing | General disorders | Systematic Assessment |
| ||
| Not -cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Postoperative wound infection | Infections and infestations | Systematic Assessment |
| ||
| Staphylococcal infection | Infections and infestations | Systematic Assessment |
| ||
| Device related infection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Medical device complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Postoperative wound infection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound infection staphylococcal | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Prothrombin level abnormal | Investigations | Systematic Assessment |
| ||
| Foot fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint instability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoporosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Alcohol withdrawal syndrome | Psychiatric disorders | Systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Osteotomy | Surgical and medical procedures | Systematic Assessment |
| ||
| Aortic steonsis | Vascular disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Vascular disorders | Systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Roach | Wright Medical | 615-656-7466 | Stephen.Roach@wright.com |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|