Actively Recruiting
A Prospective, Randomized, Single-blind, Controlled, Multi-center Study to Assess the Safety and Performance of MagnetOs Compared to Autogenous Bone Graft for Hindfoot or Ankle Fusion Surgery
Led by Kuros Biosurgery AG · Updated on 2026-04-09
126
Participants Needed
5
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of MagnetOs Putty and MagnetOs Easypack Putty, compared to autogenous bone graft, in patients undergoing hindfoot or ankle fusion surgeries. This phase IV post-marketing study focuses on treating hindfoot and ankle disorders, where synthetic bone graft extenders like MagnetOs products are routinely used by surgeons. The trial aims to assess bone fusion and functional outcomes in patients receiving these treatments. Patients will be randomly assigned to receive either MagnetOs Putty/Easypack Putty or a local autograft harvested from the calcaneus, distal tibia, or proximal tibia. Both treatments will be used with rigid hardware fixation during fusion surgeries such as ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or double fusion involving any two of these joints. The volume of MagnetOs or autograft used varies by joint, typically 1-5 cc for certain joints and up to 10 cc for the tibiotalar joint. Participants will be followed after surgery with visits at discharge and weeks 2, 6, 12, 24, and 52. Imaging evaluations, including radiographs and CT scans, will be performed at multiple time points to assess bone fusion and healing. The main outcome will be bone fusion measured by CT scan at 24 weeks post-operation. Additional assessments will include functional evaluations and further imaging up to one year post-surgery. Weight-bearing radiographs will begin at week 12, and safety monitoring will continue throughout the study period.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and sign informed consent
- Male or female aged 18 to 75 years
- Require hindfoot fusion surgery including ankle fusion (tibiotalar), subtalar fusion (talocalcaneal), calcaneocuboid fusion, talonavicular fusion, or double fusion of two of these joints
- Use of rigid fixation hardware such as screws, plates, staples, or nails
You will not qualify if you...
- Expected to need secondary surgery within one year after fusion
- Prior fusion or attempted fusion of the target joints
- Not able to walk (non-ambulatory)
- Surgical technique without bone graft use
- Conditions making bone grafting inadvisable as determined by surgeon
- Fractures or bone pathologies near fusion site that may affect healing
- Significant vascular impairment near graft site
- Acute or chronic infections in the operated area
- Sensory impairments like diabetes with poor nerve sensitivity or high HbA1c (>7.0)
- Metabolic disorders affecting bones (e.g., renal osteodystrophy, hypercalcemia)
- Lack of planned soft tissue coverage during surgery
- Use of medications interfering with calcium metabolism (long-term steroids or high-dose NSAIDs post-op)
- Benign or malignant tumors at the surgical site
- Active malignancy history (except non-invasive skin cancer)
- Substance abuse, psychiatric conditions, or other factors affecting healing or study compliance
- Involvement in active legal cases related to foot or ankle condition
- Participation in another investigational device study within 30 days prior to surgery
- Body mass index (BMI) over 50
- Inability to comply with post-operative visits and evaluations
- Pre-existing conditions interfering with functional measurements
- Women who are pregnant or plan to become pregnant within 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for radiographs and assessments
Duration - Surgery day plus hospital discharge period
Participants undergo hindfoot or ankle fusion surgery using either MagnetOs Putty/Easypack Putty or autograft with rigid hardware fixation.
1 surgical procedure visit and discharge visit
Duration - 52 weeks post-surgery
Participants are followed up to monitor healing and function after surgery with imaging and clinical assessments.
Visits at weeks 2, 6, 12, 24, and 52 post-surgery
Trial Site Locations
Total: 5 locations
1
Steadman Philippon Research Institute
Vail, Colorado, United States, 81657
Actively Recruiting
2
Hughston Foundation Inc
Columbus, Georgia, United States, 31909
Actively Recruiting
3
OrthoCarolina Research Institute, Inc
Charlotte, North Carolina, United States, 28207
Actively Recruiting
4
Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
5
Erlanger Orthopaedics
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
Research Team
C
Cesar Silva, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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