Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions

BioMimetic Therapeutics414 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

414

Conditions

Foot Fusion

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (37)

Tucson Orthopaedic Institute

Tucson, Arizona, United States

California Pacific Orthopaedics & Sports Medicine

San Francisco, California, United States

Santa Cruz Orthopaedic Institute

Santa Cruz, California, United States

Hartford Hospital Orthopaedic Center

Hartford, Connecticut, United States

The Center for Bone & Joint Surgery

Royal Palm Beach, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 weeks

Secondary Outcomes

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). 1. Clinically significant improvement: ≥20mm decrease from baseline 2. Detectable improvement: 10-20mm decrease from baseline 3. Maintained: \<10mm decrease from baseline and \<10mm increase from baseline 4. Deteriorated: \>10mm increase from baseline

Time frame: 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). 1. Clinically significant improvement: ≥20mm decrease from baseline 2. Detectable improvement: 10-20mm decrease from baseline 3. Maintained: \<10mm decrease from baseline and \<10mm increase from baseline 4. Deteriorated: \>10mm increase from baseline

Time frame: 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. 1. Clinically significant improvement: ≥10 point decrease from baseline 2. Improved: 5-10 point decrease from baseline 3. Maintained: \<5 point decrease from baseline and \<5 point increase from baseline 4. Deteriorated: \>5 point increase from baseline

Time frame: 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. 1. Clinically significant improvement: ≥20 point increase from baseline 2. Improved: 10-20 point increase from baseline 3. Maintained: \<10 point increase from baseline and \<10 point decrease from baseline 4. Deteriorated: \>10 point decrease from baseline

Time frame: 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. 1. Maintenance or improvement: ≥0 point increase from baseline 2. Slight Decline: 0-10 point decrease from baseline 3. Deteriorated: \>10 point decrease from baseline

Time frame: 24 and 52 weeks