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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01305356
Recruitment Status : Unknown
Verified October 2012 by BioMimetic Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : February 28, 2011
Last Update Posted : October 19, 2012
Information provided by (Responsible Party):
BioMimetic Therapeutics

Brief Summary:


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


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


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

Detailed Description:


Prospective, randomized, controlled, non-inferiority, multi-center trial


Up to 25


201 Subjects (see "Study Population")


Male and female subjects 21 years of age or older requiring a hindfoot fusion procedure involving a bone grafting procedure.


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).


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


Twenty-four month follow-up post-surgery

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : March 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Subject performance composite [ Time Frame: 24 weeks ]
    Subject Performance Composite

Secondary Outcome Measures :
  1. Joint fusion rates [ Time Frame: 24 weeks ]
    Joint fusion rates

  2. Clinical healing [ Time Frame: 24 weeks ]
    Clinical healing

  3. Composite success measures [ Time Frame: 24 weeks ]
    Composite success measures

  4. Therapeutic failure [ Time Frame: 24 weeks ]
    Therapeutic failure

  5. Pain [ Time Frame: 24 weeks ]
    Subject pain scores

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01305356

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

Responsible Party: BioMimetic Therapeutics Identifier: NCT01305356     History of Changes
Other Study ID Numbers: BMTI-2010-01
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: October 19, 2012
Last Verified: October 2012

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

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