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.
Procedure: Autogenous Bone Graft (ABG)
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT03028415
Ages eligible for Study
18 Years to 74 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT03028415
United States (11)
Arizona Research Center, LLC
Phoenix, Arizona, United States, 85053
Emory Orthopaedic and Spine Hospital
Atlanta, Georgia, United States, 30084
Midwest Orthopedics at Rush
Chicago, Illinois, United States, 60612
Research and Education Institute
Grand Rapids, Michigan, United States, 49525
Desert Orthopedic Center
Las Vegas, Nevada, United States, 89121
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Charlotte, North Carolina, United States, 28207
University Orthopedics Center
State College, Pennsylvania, United States, 16801
Baylor College of Medicine
Houston, Texas, United States, 77030
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Central Alberta Orthopedics
Red Deer, Alberta, Canada, T4N 6S4
Queen Elizabeth II Heath Sciences Centre
Halifax, Nova Scotia, Canada, NS B3H
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
View full eligibility
Tris trial is registered with FDA with number: NCT03028415. The sponsor of the trial is Ferring Pharmaceuticals and it is looking for 56 volunteers for the current phase.
Official trial 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
1What's a trial
4Get in touch
What's a trial
Not sure you're well informed about clinical trials? Learn more about their benefits, risks and other important details.
Enter your details like condition, age, gender and other preferences and we will show you a list of all relevant clinical trials.
Review the summary of the selected clinical trial and all the locations near you in order to see if it's of interest to you.
Get in touch
You've found an interesting trial? We'll need a bit more information about you so we can connect you to the doctor in charge.
Thank you for applying!
We'll contact you soon with more information.
Consult your doctor?
Some people want to consult their doctor before considering participation in a clinical trial. This is absolutely normal as your doctor should know your medical history and should be able to advise you. If you want you can easily share the information for this trial with your doctor by clicking on the button below.