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

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ClinicalTrials.gov Identifier: NCT00583375
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : February 23, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
BioMimetic Therapeutics

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Foot Fusion Device: Augment® Bone Graft Procedure: Standard of Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 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® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
Study Start Date : April 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Group 1

Standard Rigid Fixation plus autograft

Standard of Care: Autologous Bone Graft

Procedure: Standard of Care
Autologous Bone Graft
Experimental: Group 2
Standard Rigid Fixation plus Augment® Bone Graft
Device: Augment® Bone Graft
Augment® Bone Graft



Primary Outcome Measures :
  1. Subjects Fused at 24 Weeks (as Determined by CT Assessment) [ Time Frame: 24 weeks ]
    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.


Secondary Outcome Measures :
  1. Pain on Weight Bearing [ Time Frame: 24 and 52 Weeks ]

    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

  2. Pain at Fusion Site [ Time Frame: 24 and 52 weeks ]

    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

  3. Foot Function Index (FFI) [ Time Frame: 24 and 52 weeks ]

    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

  4. AOFAS Hindfoot and Ankle Score [ Time Frame: 24 and 52 weeks ]

    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

  5. SF-12 Physical Component Score [ Time Frame: 24 and 52 weeks ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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 ClinicalTrials.gov identifier (NCT number): NCT00583375


  Show 37 Study Locations
Sponsors and Collaborators
BioMimetic Therapeutics
Investigators
Principal Investigator: Christopher DiGiovanni, M.D. Rhode Island Hospital

Responsible Party: BioMimetic Therapeutics
ClinicalTrials.gov Identifier: NCT00583375     History of Changes
Other Study ID Numbers: BMTI-2006-01
First Posted: December 31, 2007    Key Record Dates
Results First Posted: February 23, 2018
Last Update Posted: April 2, 2018
Last Verified: March 2018

Keywords provided by BioMimetic Therapeutics:
arthritis
ankle pain
foot pain
hindfoot fracture
ankle fracture