MagnetOs for Ankle Fusion
(ASTRA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of MagnetOs Putty and MagnetOs Easypack Putty as bone graft alternatives for ankle and hindfoot surgeries. Researchers aim to determine how well these synthetic products promote bone healing compared to traditional bone grafts. The trial seeks participants who require ankle fusion surgery using screws or plates and have not previously attempted fusion in the affected joints. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future surgical outcomes.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but it excludes those on medications that interfere with calcium metabolism, like chronic glucocorticoids or high-dose NSAIDs. It's best to discuss your specific medications with the trial team.
What is the safety track record for MagnetOs Putty and MagnetOs Easypack Putty?
Research has shown that MagnetOs Putty and MagnetOs Easypack Putty have yielded good results in earlier studies. Patients experienced positive outcomes, and no major safety issues emerged. A review of past cases demonstrated that these products help bones join together effectively and safely. Surgeons use them in foot and ankle procedures, and they are generally well-tolerated. These products are already in use, and this study aims to confirm their safety and effectiveness.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about MagnetOs because it offers a novel approach to ankle fusion. Unlike traditional methods that often use an autograft, which involves harvesting bone from the patient’s own body, MagnetOs uses a synthetic bone graft substitute. This substitute is designed to promote bone growth and healing more efficiently. Additionally, MagnetOs is available in an easy-to-use putty form, which could simplify the surgical process and potentially lead to better outcomes for patients.
What is the effectiveness track record for MagnetOs in treating hindfoot and ankle disorders?
This trial will compare the effectiveness of MagnetOs products with an autograft for ankle fusion. Studies have shown that MagnetOs Putty and MagnetOs Easypack Putty effectively help bones fuse. In a previous study, patients who used MagnetOs Putty for spinal surgeries achieved a 92.73% success rate in bone fusion within a year, even among high-risk groups. This synthetic bone graft features a special surface that aids bone cell adhesion and growth. Research indicates that MagnetOs products may enhance the success of bone fusion surgeries, suggesting potential benefits for ankle fusion as well. These findings support MagnetOs as a reliable option for those undergoing ankle fusion procedures.12346
Are You a Good Fit for This Trial?
This trial is for patients needing hindfoot or ankle fusions due to deformities, dysfunctions, or other pathologies. Participants should be suitable for surgery and willing to follow the study procedures. Specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo hindfoot or ankle fusion surgery using either MagnetOs Putty/Easypack Putty or autograft
Post-operative Follow-up
Participants are monitored for safety and efficacy with follow-up visits at discharge, weeks 2, 6, 12, 24, and 52 post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- MagnetOs
Trial Overview
The safety and performance of MagnetOs Putty products are being tested against traditional autografts (patient's own bone) in foot and ankle surgeries. This phase IV study uses these putties as a synthetic bone graft extender in a randomized, single-blind manner across multiple centers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Interventions * Procedure: Instrumented hindfoot or ankle fusion * Device: MagnetOs Putty or MagnetOs Easypack Putty
Interventions * Procedure: Instrumented hindfoot or ankle fusion * Device: Autograft
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kuros Biosurgery AG
Lead Sponsor
Citations
NCT07225751 | A Prospective, Randomized, Single-blind ...
This is a phase IV post-marketing study for MagnetOs Putty and MagnetOs Easypack Putty. MagnetOs is a synthetic bone graft extender product ...
MagnetOs Putty
MagnetOs Putty delivers all the benefits of our established MagnetOs family thanks to our unique NeedleGrip™ surface technology.
Project Fusion
Retrospective: Lumbar interbodies, 92.73% fusion rate at one year, high risk patient cohorts, MagnetOs Putty.
4.
orthopedicreviews.openmedicalpublishing.org
orthopedicreviews.openmedicalpublishing.org/article/133986A retrospective review of MagnetOs Easypack Putty^TM ...
Cumulatively, these clinical fusion and VAS outcomes data have the potential to impact the safety and success of interbody fusion procedures.
5.
neurospineproductreview.com
neurospineproductreview.com/storage/products/pdfs/kuros-global-research-summary-2025.pdfMagnetOs™ Global Research Summary - NeuroSpine
Early Radiographic and Clinical Outcomes of Three Patients. Undergoing Open Instrumented Posterolateral Fusion Surgery with MagnetOs Easypack Putty. JOJ Case.
MagnetOs Clinical Evidence
Abstract: Patients with diabetes mellitus who sustain ankle fractures are at increased risk of complications including non-union, malunion, wound dehiscence, ...
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