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AMPLEX Ankle Fusion

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ClinicalTrials.gov Identifier: NCT03028415
Recruitment Status : Recruiting
First Posted : January 23, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
To demonstrate that AMPLEX is non-inferior to autogenous bone graft (ABG) for bone fusion in a population indicated for single, double, or triple hindfoot arthrodesis or ankle arthrodesis surgery with supplemental graft material.

Condition or disease Intervention/treatment Phase
Arthrodesis Surgery Involving the Hindfoot or Ankle Device: AMPLEX® Procedure: Autogenous Bone Graft (ABG) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX® Compared To Autogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfoot or Ankle
Actual Study Start Date : July 28, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: AMPLEX® Device: AMPLEX®
A bone graft substitute

Active Comparator: Autogenous Bone Graft (ABG) Procedure: Autogenous Bone Graft (ABG)
Control material administered by surgical implant




Primary Outcome Measures :
  1. Proportion of subjects who meet all following five criteria for Subject Performance Composite (SPC) Endpoint [ Time Frame: At week 52 ]
    1. Improvement in pain on weight-bearing at fusion site (≥ 20 mm reduction from baseline on 100 mm Visual Analog Scale (VAS) 2. Absence of significant graft harvest site pain (< 20 mm on 100 mm VAS) 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥ 8 points improvement from baseline) 4. Absence of device related or procedure related Serious Adverse Events (up to week 52) 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion (up to week 52)


Secondary Outcome Measures :
  1. Proportion of subjects with radiographic evidence of fusion by Computerized Tomography (CT) scan [ Time Frame: At week 52 ]
    Defined as ≥ 50% bone bridging across the joint space for the full complement of joints in the absence of secondary surgical or nonsurgical interventions intended to promote fusion

  2. Proportion of subjects achieving CT radiographic fusion success [ Time Frame: At 12 and 24 weeks ]
    Must be in the absence of secondary surgical or nonsurgical interventions intended to promote fusion

  3. Change from baseline in pain on weight-bearing at fusion site [ Time Frame: At 12, 24 and 52 weeks ]
    Defined as ≥ 20 mm reduction from baseline on 100 mm VAS

  4. Absence of graft harvest site pain [ Time Frame: At 2, 6, 12, 24 and 52 weeks ]
    Defined as < 20 mm on 100 mm VAS

  5. Change from baseline in FAAM-ADL [ Time Frame: At 12, 24 and 52 weeks ]
    Functional improvement measured by the Foot and Ankle Ability Measure of Activities of Daily Living (FAAM-ADL) scale. The FAAM-ADL scale is a subject self-assessment questionnaire that focuses on activities of daily living

  6. Subject Performance Composite (SPC) Endpoint [ Time Frame: At 12 and 24 weeks ]
    Assessed by 1. Improvement in pain on weight-bearing at fusion site (≥ 20 mm reduction from baseline on 100 mm Visual Analog Scale (VAS) 2. Absence of significant graft harvest site pain (< 20 mm on 100 mm VAS) 3. Improvement in Foot and Ankle Ability Measure Activities of Daily Living subscale (FAAM-ADL) (≥ 8 points improvement from baseline) 4. Absence of device related or procedure related Serious Adverse Events (SAEs) 5. Absence of secondary surgical or nonsurgical interventions intended to promote fusion

  7. Change from baseline in Short Form-12 (SF-12) Questionnaire [ Time Frame: At 24 and 52 weeks ]
    Collected by questionnaires completed by subjects that focus on physical and social functioning, including questions on pain, energy/fatigue and general health



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indicated for ankle or hindfoot arthrodesis and require one of the following arthrodesis procedures:

Tibiotalar (ankle); Talocalcaneal (subtalar); Talonavicular; Calcaneocuboid; Double hindfoot (e.g., talonavicular and talocalcaneal joints); Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints)

  • Presents with pain on weight-bearing of at least 40 mm on a 100 mm VAS at the area indicated for arthrodesis
  • Presents with at least one comorbid risk factors that warrant the use of supplemental autogenous bone or allograft:

Radiographic evidence of bone defect, deficit, subsidence or subchondral cyst; More than one joint to be fused; Involvement of other adjacent or nonadjacent joints; Large surface area; Intra-articular or extra-articular deformity; Post-traumatic arthritis; Diagnosis of osteoporosis

  • The Investigator determines if the joint space(s) can be adequately filled with graft material (AMPLEX or ABG) according to the following parameters:

Single hindfoot joint fusion: up to 5 cm3; Double or triple hindfoot fusion: each individual joint up to 5 cm3, but overall, not more than 10 cm3 for the full complement of joints; Ankle fusion: up to 10 cm3

  • Each fused joint can be rigidly stabilized with no more than 3 screws across the fusion plane. (Supplemental pins and staples may be used, as well as supplemental screws and plates external to the fusion site(s).)
  • For women of childbearing potential (not post-menopausal for 12 months or surgically sterile), a urine pregnancy test with a negative result must be obtained at screening and on the day of surgery, prior to procedure. These trial participants must commit to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence) through the 78 week follow-up

Exclusion Criteria:

  • Bone deficit requiring a structural graft
  • Charcot foot disease
  • Radiographic evidence of open epiphyses
  • Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joint(s)
  • Requires osteotomy or fusion of the midfoot joints
  • BMI greater than 45 kg/m2
  • Documented medical history of, or radiographic evidence of, a bone disease (e.g. avascular necrosis) or other condition (e.g., osteolysis) that would preclude the subject from receiving screw fixation in the opinion of the surgeon
  • Requires intramedullary nail fixation or an external fixator
  • Comorbidity that would limit the ability to administer any functional measurements such as FAAM-ADL
  • Has at the time of surgery, a systemic infection or local infection at the site of surgery
  • Medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study or potentially decrease survival or interfere with ambulation or rehabilitation (e.g., history of transient ischemic attack, stroke or liver disease)
  • HgbA1c level greater than or equal to 8%
  • Known hypersensitivity to any of the components of the product [e.g. B2A peptide, Hydroxyapatite (HA): beta-tricalcium phosphate (βTCP), ceramic granule]
  • Has previously been treated with, or exposed to, therapeutic levels of synthetic or recombinant Bone Morphogenetic Proteins (BMPs)
  • Requires chronic subcutaneous or intravenous heparin therapies

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): NCT03028415


Contacts
Contact: Global Clinical Compliance +1 833-548-1402 DK0-Disclosure@ferring.com

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Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03028415     History of Changes
Other Study ID Numbers: 000226
G150153 ( Other Identifier: IDE Number )
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes