NCT07225751 · Kuros Biosurgery AG
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.
(ASTRA)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
- Male or female patient ≥ 18 (considered skeletally mature) up to and including 75 years old
- 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, talonavicular and calcaneocuboid joints).
- Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination.
Exclusion criteria
- Expected to need secondary intervention within one year following surgery.
- Had prior fusion or attempted fusion of the joints to be fused.
- Patient is not ambulatory.
- Surgical technique where bone graft is not expected to be used.
- Conditions at the surgeon's discretion in which general bone grafting is not advisable.
- Radiographic evidence of fractures or pathologies around the fusion that could negatively impact the fusion process (e.g., growth plate fracture around the fusion or bone cysts).
- Significant vascular impairment proximal to the graft site.
- Acute and/or chronic infections in the operated area (soft tissue infections; bacterial bone diseases; osteomyelitis)
- Pre-existing sensory impairment (e.g. diabetes, Charcot). Diabetics patients with HbA1c greater than 7.0 OR that were not sensitive to the 5.07 monofilament will be excluded.
- Metabolic disorders know to adversely affect the skeleton (e.g., renal osteodystrophy or hypercalcemia).
- If intraoperative soft tissue coverage is not planned or possible.
- Receiving treatment with medication interfering with calcium metabolism (chronic use of glucocorticoid and use high dose NSAIDs 800 mg TID for \> the first 6 weeks post-op).
- Has benign or malignant tumor at the surgical site.
- Has history or presence of active malignancy (non-invasive skin cancer is allowed).
- Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements (e.g. prisoners, physically or mentally compromised, etc.).
- Is involved in active litigation relating to his/her foot and ankle condition.
- Participation in an investigational study within 30 days prior to surgery for study devices.
- Patient with body mass index (BMI) \> 50.
- Patient cannot comply with all post-operative evaluation and visits .
- Any pre-existing condition that the surgeon determines could interfere with the patient's ability to perform objective functional measurements.
- Women who are or intend to become pregnant within the next 12 months.
Where
- Vail, Colorado
- Columbus, Georgia
- Charlotte, North Carolina
- Philadelphia, Pennsylvania
- Chattanooga, Tennessee
- Falls Church, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 7, 2026 · Source of record for eligibility and locations