MagnetOs for Ankle Fusion

(ASTRA Trial)

Overseen By Cesar Silva, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kuros Biosurgery AG

Must not be taking: Glucocorticoids, High-dose NSAIDs

Disqualifiers: Non-ambulatory, Diabetes, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 1 day (surgery)

126 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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

Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent

Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination

I am between 18 and 75 years old.

Exclusion Criteria

I cannot walk by myself.

Patient with body mass index (BMI) > 50

Expected to need secondary intervention within one year following surgery

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

1 visit (in-person)

Treatment

Participants undergo hindfoot or ankle fusion surgery using either MagnetOs Putty/Easypack Putty or autograft

1 day (surgery)

1 visit (in-person)

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

52 weeks

6 visits (in-person)

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?

Group I: MagnetOs Experimental Treatment 1 Intervention

Interventions * Procedure: Instrumented hindfoot or ankle fusion * Device: MagnetOs Putty or MagnetOs Easypack Putty

Group II: Autograft Active Control 1 Intervention

Interventions * Procedure: Instrumented hindfoot or ankle fusion * Device: Autograft

Who Is Running the Clinical Trial?

Kuros Biosurgery AG

Lead Sponsor

Trials

11

Recruited

910+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225751

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 ...

2. kurosbio.com kurosbio.com/extremities/putty/

MagnetOs Putty MagnetOs Putty delivers all the benefits of our established MagnetOs family thanks to our unique NeedleGrip™ surface technology.

3. kurosbio.com kurosbio.com/project-fusion/

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/133986

A 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.pdf

MagnetOs™ Global Research Summary - NeuroSpine Early Radiographic and Clinical Outcomes of Three Patients. Undergoing Open Instrumented Posterolateral Fusion Surgery with MagnetOs Easypack Putty. JOJ Case.

6. kurosbio.com kurosbio.com/resources/clinical-radiographic-and-histologic-outcomes-of-ankle-arthrodesis-in-a-diabetic-patient-using-a-biphasic-calcium-phosphate-bone-graft-with-a-novel-submicron-needle-shaped-surface-topography/

MagnetOs Clinical Evidence Abstract: Patients with diabetes mellitus who sustain ankle fractures are at increased risk of complications including non-union, malunion, wound dehiscence, ...