Actively Recruiting
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.
Led by Kuros Biosurgery AG · Updated on 2026-04-09
126
Participants Needed
5
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Patient can read, understand, and provide written informed consent
- Male or female aged 18 to 75 years
- Requires hindfoot fusion procedure needing rigid hardware fixation and bone graft or substitute (ankle fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, or double fusion of any two joints)
- Surgical hardware includes screws, plates, staples, nails, or combinations for rigid fixation
You will not qualify if you...
- Expected to need secondary intervention within one year after surgery
- Prior fusion or attempted fusion of the joints to be fused
- Not ambulatory
- Surgical technique does not use bone graft
- Conditions where bone grafting is not advisable as determined by surgeon
- Radiographic evidence of fractures or pathologies around fusion site affecting fusion
- Significant vascular impairment near graft site
- Acute or chronic infections in operated area
- Pre-existing sensory impairment such as diabetes with HbA1c >7.0 or insensitivity to 5.07 monofilament
- Metabolic disorders affecting the skeleton
- Intraoperative soft tissue coverage not planned or possible
- Taking medications interfering with calcium metabolism (chronic glucocorticoids, high dose NSAIDs for first 6 weeks post-op)
- Benign or malignant tumor at surgical site
- History or presence of active malignancy (except non-invasive skin cancer)
- Known substance abuse, psychiatric disorder, or condition affecting healing or compliance
- Involved in active litigation related to foot and ankle condition
- Participation in investigational study within 30 days prior to surgery
- Body mass index (BMI) over 50
- Unable to comply with post-operative evaluations and visits
- Any condition interfering with objective functional measurements
- Women who are or intend to become pregnant within 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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