A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOsTM Compared to Autogenous Bone Graft in Patients Undergoing Hindfoot or Ankle Fusions
Kuros Biosurgery AG
Summary
This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product that is routinely used by surgeon as treatment for hindfoot and ankle disorders. In this study, MagnetOs Putty and MagnetOs Easypack Putty will be use according to the latest Instructions For Use, standalone in the foot and ankle.
Description
In this study, following a screening period of a maximum of 45 days, approximately 126 patients will receive either MagnetOs Putty/Easypack Putty or autograft in conjunction with rigid hardware (arthrodesis) to treat hindfoot and ankle disorders. They will be randomized (1:1) into one of two treatment groups: standard rigid fixation with MagnetOs Putty/Easypack Putty or local autograft from the calcaneus, distal tibia, or proximal tibia. They will be followed up at discharge at weeks 2, 6, 12, 24 and 52 post-surgery. The primary endpoint will be analyzed at 24 weeks post-op using CT-scan, and…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion: 1. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent. 2. Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old 3. Patients requiring one of the following hindfoot fusion procedures, using surgical technique, necessitating rigid hardware fixation and supplemental bone graft/ substitute: ankle fusion (tibiotalar) subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, OR double fusion (any combination of any two of the following: subtalar, talon…
Interventions
- DeviceMagnetOs
MagnetOs will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.
- OtherAutograft
In this study, the comparator is autograft and will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.
Locations (5)
- Steadman Philippon Research InstituteVail, Colorado
- Hughston Foundation IncColumbus, Georgia
- OrthoCarolina Research Institute, IncCharlotte, North Carolina
- Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic InstitutePhiladelphia, Pennsylvania
- Erlanger OrthopaedicsChattanooga, Tennessee