Overview

This trial is active, not recruiting.

Conditions degenerative joint disease, congenital deformity, arthritis, osteoarthritis, rheumatoid arthritis
Treatments augment(tm) injectable bone graft, autologous bone graft
Phase phase 3
Sponsor BioMimetic Therapeutics
Start date March 2011
End date April 2013
Trial size 201 participants
Trial identifier NCT01305356, BMTI-2010-01

Summary

STUDY OBJECTIVES:

To demonstrate equivalent clinical and radiologic outcomes as "gold standard" (Autologous Bone Graft) in a representative clinical model (hindfoot fusions)

STUDY HYPOTHESIS:

Augment™ Injectable is an equivalent bone grafting substitute to autologous bone graft in applications as shown by superiority analysis for safety and non-inferiority analysis for effectiveness

STUDY RATIONALE:

To evaluate a fully synthetic bone graft material 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 Autologous Bone Graft without necessitating an additional invasive procedure to harvest the graft

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Standard Rigid Fixation + Autologous bone graft
autologous bone graft
Implantation of up to 9cc of autologous bone graft
(Experimental)
Standard rigid fixation + Augment(tm) Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
augment(tm) injectable bone graft
Implantation of up to 9cc of Augment(tm) Injectable Bone Graft

Primary Outcomes

Measure
Subject performance composite
time frame: 24 weeks

Secondary Outcomes

Measure
Joint fusion rates
time frame: 24 weeks
Clinical healing
time frame: 24 weeks
Composite success measures
time frame: 24 weeks
Therapeutic failure
time frame: 24 weeks
Pain
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 21 years old.

KEY INCLUSION CRITERIA: - The subject is diagnosed with degenerative joint disease (DJD) affecting the hindfoot due to a congenital or acquired deformity, osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or ankylosing spondylitis of the subtalar, calcaneocuboid, and/or talonavicular joints. - The subject requires hindfoot fusion with supplemental bone graft/substitute, requiring one of the following procedures: - Subtalar fusion (talocalcaneal) - Calcaneocuboid fusion - Talonavicular fusion - Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints) - Double fusions (any combination of any two of the following: subtalar, talonavicular and calcaneocuboid joints) - The fusion site is able to be rigidly stabilized with screw fixation - The subject is at least 21 years of age and considered to be skeletally mature. KEY EXCLUSION CRITERIA: - The subject has undergone previous fusion surgery of the proposed site (i.e., revision of failed fusion attempt). - The subject has retained hardware spanning the joint(s) intended for fusion. - The procedure is anticipated to require use of plate fixation (including claw plates), intramedullary rods (or nails), or more than three (3) screws across the fusion site to achieve rigid fixation. - The subject requires a pantalar fusion (i.e. fusion of the ankle plus all hindfoot joints [talonavicular, subtalar, and calcaneocuboid]) or an ankle fusion in combination with any hindfoot fusion. - The subject has tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or are currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body. - The subject uses chronic medications known to affect the skeleton (e.g., glucocorticoid usage >10mg/day). - The subject has a diagnosis or history of bi-polar disorder, schizophrenia, suicidal ideation, post traumatic stress disorder, senile dementia or Alzheimer's disease. - The subject has an allergy to yeast-derived products. - The subject has an allergy to bovine collagen and/or other bovine source medication, supplements or products. - The subject is pregnant or a female intending to become pregnant within 12 months of the study procedure. - The subject is deemed morbidly obese (BMI >45 kg/m2). - The subject refuses to discontinue using tobacco products prior to surgery.

Additional Information

Official title A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
Principal investigator Christopher DiGiovanni, MD
Description STUDY DESIGN: Prospective, randomized, controlled, non-inferiority, multi-center trial NUMBER OF STUDY CENTERS: Up to 25 NUMBER OF SUBJECTS: 201 Subjects (see "Study Population") STUDY POPULATION: Male and female subjects 21 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure. TREATMENT GROUPS: Group I: Standard Rigid Fixation + Autologous Bone Graft Group II: Standard Rigid Fixation + Augment™ Injectable Bone Graft Subjects will be randomized in a 2:1 ratio (Augment™ Injectable:Autologous Bone Graft). ROUTE OF ADMINISTRATION: Investigational device is manually implanted inside and around the fusion space to ensure Augment™ Injectable Bone Graft (beta-TCP/bovine collagen matrix +rhPDGF-BB) or autologous bone graft is contained within the joint space STUDY DURATION: Twenty-four month follow-up post-surgery
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by BioMimetic Therapeutics.