AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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.

RecruitingNAAges 18 Years - 75 YearsAllKuros Biosurgery AG
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion: 1. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent. 2. Male or female patient โ‰ฅ 18 (considered skeletally mature) up to and including 75 years old 3. 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). 4. Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination. Exclusion: 1. Expected to need secondary intervention within one year following surgery. 2. Had prior fusion or attempted fusion of the joints to be fused. 3. Patient is not ambulatory. 4. Surgical technique where bone graft is not expected to be used. 5. Conditions at the surgeon's discretion in which general bone grafting is not advisable. 6. 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). 7. Significant vascular impairment proximal to the graft site. 8. Acute and/or chronic infections in the operated area (soft tissue infections; bacterial bone diseases; osteomyelitis) 9. 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. 10. Metabolic disorders know to adversely affect the skeleton (e.g., renal osteodystrophy or hypercalcemia). 11. If intraoperative soft tissue coverage is not planned or possible. 12. 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). 13. Has benign or malignant tumor at the surgical site. 14. Has history or presence of active malignancy (non-invasive skin cancer is allowed). 15. 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.). 16. Is involved in active litigation relating to his/her foot and ankle condition. 17. Participation in an investigational study within 30 days prior to surgery for study devices. 18. Patient with body mass index (BMI) \> 50. 19. Patient cannot comply with all post-operative evaluation and visits . 20. Any pre-existing condition that the surgeon determines could interfere with the patient's ability to perform objective functional measurements. 21. Women who are or intend to become pregnant within the next 12 months.
๐Ÿ’Š

What it tests

  • MagnetOs
  • Autograft
๐Ÿ“

Where

7 sites
University California Davis
Sacramento, United States
Steadman Philippon Research Institute
Vail, United States
Hughston Foundation Inc
Columbus, United States
OrthoCarolina Research Institute, Inc
Charlotte, United States
Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute
Philadelphia, United States
Integrity Orthopedics and Sports Medicine
Chattanooga, United States
Centers for Advanced Orthopaedics
Falls Church, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy