A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX® Compared ToAutogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfootor Ankle
The purpose of the study is 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 (fusion) or ankle arthrodesis (fusion) surgery with supplemental graft material.
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
We will enroll patients between the ages of 18-75 years who are 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)
Additionally, the following are required-
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
Primary disease category: Orthopaedics, Muscle & Bone
Sponsor: Ferring International Pharmascience Center U.S., Inc. (FIPCUS)
Projected enrollment dates: May 2018 to December 2020
Official study title: A Multi-Center, Randomized, Pivotal Study Evaluating AMPLEX® Compared ToAutogenous Bone Graft in Subjects Indicated for Arthrodesis Surgery Involving the Hindfootor Ankle