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

February 25, 2011
October 18, 2012
March 2011
April 2013   (final data collection date for primary outcome measure)
Subject performance composite [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Subject Performance Composite
Subject performance composite [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Radiographic evidence of fusion success, clinical improvement and absence of any secondary procedures for the subject, absence of significant weight-bearing pain and graft harvest site pain, improvement in subject function, and absence of serious side effects for the subject
Complete list of historical versions of study NCT01305356 on ClinicalTrials.gov Archive Site
  • 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
  • Joint fusion rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Joint fusion rate at 24 weeks
  • CT fusion [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    CT fusion based on individual joints
  • Radiographic fusion [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Radiographic fusion rate based on full complement of joints
  • Radiographic fusion [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Radiographic fusion rate based on individual joints
  • Clinical healing at the patient level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Clinical healing at the patient level
  • Clinical healing at the joint level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Clinical healing at the joint level
  • Clinical success [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Clinical success
  • Composite success [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Composite success
  • Functional success [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Functional success
  • Therapeutic failure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Therapeutic failure
  • Functional and Quality of Life Measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    SF-12, FFI, AOFAS scores
  • Pain [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    VAS pain scores
Not Provided
Not Provided
 
Augment™ Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Hindfoot Fusions
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 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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Degenerative Joint Disease
  • Congenital Deformity
  • Arthritis
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Device: Augment(tm) Injectable Bone Graft
    Implantation of up to 9cc of Augment(tm) Injectable Bone Graft
  • Procedure: Autologous bone graft
    Implantation of up to 9cc of autologous bone graft
  • Active Comparator: Autologous bone graft
    Standard Rigid Fixation + Autologous bone graft
    Intervention: Procedure: Autologous bone graft
  • Experimental: Augment(tm) Injectable Bone Graft
    Standard rigid fixation + Augment(tm) Injectable Bone Graft (beta-TCP/bovine collagen matrix + rhPDGF-BB)
    Intervention: Device: Augment(tm) Injectable Bone Graft
DiGiovanni CW, Petricek JM. The evolution of rhPDGF-BB in musculoskeletal repair and its role in foot and ankle fusion surgery. Foot Ankle Clin. 2010 Dec;15(4):621-40. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
201
April 2014
April 2013   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01305356
BMTI-2010-01
No
BioMimetic Therapeutics
BioMimetic Therapeutics
Not Provided
Study Director: Stephen Roach BioMimetic Therapeutics, Inc.
Principal Investigator: Christopher DiGiovanni, MD University Orthopaedics, Inc.
BioMimetic Therapeutics
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP