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Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
BioMimetic Therapeutics
ClinicalTrials.gov Identifier:
NCT01305356
First received: February 25, 2011
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Degenerative Joint Disease
Congenital Deformity
Arthritis
Osteoarthritis
Rheumatoid Arthritis
 Device: Augment(tm) Injectable Bone Graft
Procedure: Autologous bone graft
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioMimetic Therapeutics:

Primary Outcome Measures:
  • Subject performance composite [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Subject Performance Composite


Secondary Outcome Measures:
  • Joint fusion rates [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Joint fusion rates

  • Clinical healing [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Clinical healing

  • Composite success measures [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Composite success measures

  • Therapeutic failure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Therapeutic failure

  • Pain [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Subject pain scores


Estimated Enrollment: 201
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Autologous bone graft
Standard Rigid Fixation + Autologous bone graft
 Procedure: Autologous bone graft
Implantation of up to 9cc of autologous bone graft
Experimental: Augment(tm) Injectable Bone Graft
Standard rigid fixation + Augment(tm) Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
 Device: Augment(tm) Injectable Bone Graft
Implantation of up to 9cc of Augment(tm) Injectable Bone Graft

Detailed 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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305356

  Show 26 Study Locations
Sponsors and Collaborators
BioMimetic Therapeutics
Investigators
Study Director: Stephen Roach BioMimetic Therapeutics, Inc.
Principal Investigator: Christopher DiGiovanni, MD University Orthopaedics, Inc.
  More Information

Publications:

Responsible Party: BioMimetic Therapeutics
ClinicalTrials.gov Identifier: NCT01305356     History of Changes
Other Study ID Numbers: BMTI-2010-01
Study First Received: February 25, 2011
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMimetic Therapeutics:
degenerative joint disease
DJD
joint fusion
hindfoot
congenital deformity
osteoarthritis
rheumatoid arthritis
post-traumatic arthritis
 ankylosing spondylitis
Augment(tm) Injectable Bone Graft
autologous bone graft
autogenous bone graft
beta-TCP
bovine collagen
rhPDGF(bb)

Additional relevant MeSH terms:
Congenital Abnormalities
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Osteoarthritis
 Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013