AMPLEX Ankle Fusion and Hindfoot

NCT03028415 | Completed Results DMC FDA Device

• 2 other identifiers: 000226G150153
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 36

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.

Conditions

Arthrodesis Surgery Involving the Hindfoot or Ankle

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Who Met All Five Criteria for Subject Performance Composite (SPC) Endpoint

  Proportion of subjects who met all the following criteria for the SPC endpoint at 52 weeks: 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). The last observation carried forward was used for subjects with missing response status at 52 weeks.

  At week 52

Secondary Outcomes (18)

• Proportion of Subjects Achieving Computerized Tomography (CT) Radiographic Fusion Success

  At week 52

• Proportion of Subjects Achieving CT Radiographic Fusion Success

  At week 12

• Proportion of Subjects Achieving CT Radiographic Fusion Success

  At week 24

• Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)

  Baseline, and at week 12

• Proportion of Subjects With Change From Baseline in Pain on Weight-bearing at Fusion Site (>20 mm Reduction From Baseline on 100 mm VAS)

  Baseline, and at week 24

Study Arms (2)

AMPLEX

EXPERIMENTAL

Device: AMPLEX

Autogenous Bone Graft (ABG)

ACTIVE COMPARATOR

Procedure: Autogenous Bone Graft (ABG)

Interventions

AMPLEX DEVICE

A bone graft substitute

AMPLEX

Autogenous Bone Graft (ABG) PROCEDURE

Control material administered by surgical implant

Autogenous Bone Graft (ABG)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• 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 cm\^3; Double or triple hindfoot fusion: each individual joint up to 5 cm\^3, but overall, not more than 10 cm3 for the full complement of joints; Ankle fusion: up to 10 cm\^3
• Each fused joint can be rigidly stabilized with with at least 1 and 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))
• Willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations
• 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 within 24 hours 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

You may not qualify if:

• Bone deficit requiring a structural graft
• Charcot foot disease
• Radiographic evidence of open physes
• 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/m\^2
• 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 \[e.g. B2A peptide, Hydroxyapatite (HA): beta-tricalcium phosphate (βTCP), ceramic granule\]
• Currently receiving treatment with a drug known to interfere with bone metabolism \[e.g., systemic corticosteroid therapy (topical corticosteroid therapy is permissible), methotrexate\]
• Has previously received treatment with a drug known to interfere with bone metabolism \[e.g., systemic corticosteroid therapy (topical corticosteroid therapy is permissible), methotrexate\] and in the opinion of the investigator could continue to negatively interfere with bone metabolism or bone healing

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (36)

Physician Research Group

Gilbert, Arizona, 85295, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

California Pacific Orthopaedics

San Francisco, California, 94118, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Andrews Orthopaedic and Sports Medicine Center

Gulf Breeze, Florida, 32561, United States

Location

Emory Orthopaedic and Spine Hospital

Atlanta, Georgia, 30329, United States

Location

Midwest Orthopedics at Rush

Chicago, Illinois, 60612, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Sinai Hospital of Baltimore, Inc / Rubin Institute for Advanced Orthopedics

Baltimore, Maryland, 21215, United States

Location

Medstar

Baltimore, Maryland, 21218, United States

Location

Orthopaedic Associates of Michigan, Research and Education Institute

Grand Rapids, Michigan, 49525, United States

Location

Michigan Orthopedic Center

Lansing, Michigan, 48910, United States

Location

TRIA Orthopaedic Center

Bloomington, Minnesota, 55431, United States

Location

Desert Orthopaedic Center

Las Vegas, Nevada, 89121, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Rutgers

Newark, New Jersey, 07103, United States

Location

University of Rochester School of Medicine

Rochester, New York, 14642, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Reconstructive Orthopaedic Associates

Philadelphia, Pennsylvania, 19107, United States

Location

University Orthopedics Center

State College, Pennsylvania, 16801, United States

Location

Campbell Clinic Orthopaedics

Germantown, Tennessee, 38138, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0165, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

University of Alberta System

Edmonton, Alberta, T6G 2B7, Canada

Location

Central Alberta Orthopedics

Red Deer, Alberta, T4N 6S4, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5C 1R6, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

University of Laval

Québec, Quebec, G1V 4G2, Canada

Location

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

-+1 833-548-1402

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 23, 2017
• Study Start: July 28, 2017
• Primary Completion: January 9, 2020
• Study Completion: July 9, 2020
• Last Updated: March 11, 2021
• Results First Posted: March 11, 2021

Record last verified: 2020-08

Locations

CA (8); US (28)