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Completed

NCT Number: NCT00583375

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

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

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Key information

Conditions

Foot Fusion Ankle Fractures Ankle Injuries Arthritis Fractures, Bone Joint Diseases Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Lougheed Centre, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • Previous fusion surgery of the proposed fusion site.
  • The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day).
  • Pregnant or a female intending to become pregnant during this study period.
  • Morbidly obese (BMI > 45 kg/m2)

Treatment and study plan

Augment® Bone Graft

Device

Augment® Bone Graft

Standard of care

Procedure

Autologous Bone Graft

Primary outcomes

  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 outcomes

  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).

    • Clinically significant improvement: ≥20mm decrease from baseline
    • Detectable improvement: 10-20mm decrease from baseline
    • Maintained: <10mm decrease from baseline and <10mm increase from baseline
    • 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).

    • Clinically significant improvement: ≥20mm decrease from baseline
    • Detectable improvement: 10-20mm decrease from baseline
    • Maintained: <10mm decrease from baseline and <10mm increase from baseline
    • 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.

    • Clinically significant improvement: ≥10 point decrease from baseline
    • Improved: 5-10 point decrease from baseline
    • Maintained: <5 point decrease from baseline and <5 point increase from baseline
    • 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.

    • Clinically significant improvement: ≥20 point increase from baseline
    • Improved: 10-20 point increase from baseline
    • Maintained: <10 point increase from baseline and <10 point decrease from baseline
    • 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.

    • Maintenance or improvement: ≥0 point increase from baseline
    • Slight Decline: 0-10 point decrease from baseline
    • Deteriorated: >10 point decrease from baseline

Sponsors and collaborators

Lead sponsor

BioMimetic Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 31, 2007
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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