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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MagnetOs, Autograft.
- Who it may be relevant to
- Registry conditions: Ankle Arthrodesis or Arthroplasty, Hindfoot Fusion, Ankle Deformity, Ankle Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
In this study, following a screening period of a maximum of 45 days, approximately 126 patients will receive either MagnetOs Putty/Easypack Putty or autograft in conjunction with rigid hardware (arthrodesis) to treat hindfoot and ankle disorders. They will be randomized (1:1) into one of two treatment groups: standard rigid fixation with MagnetOs Putty/Easypack Putty or local autograft from the calcaneus, distal tibia, or proximal tibia.
They will be followed up at discharge at weeks 2, 6, 12, 24 and 52 post-surgery. The primary endpoint will be analyzed at 24 weeks post-op using CT-scan, and patients will continue follow-up for safety and efficacy for one year post operatively.
In this study, MagnetOs will be applied according to the IFU (Putty) approved in the US, Europe, Middle- East and Australia and Easypack Putty (approved in the US).
The surgical procedures studied in this clinical trial will include rigid hardware fixation and supplemental bone graft/substitute in the following procedures: 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. These procedures will be left to the investigator's discretion.
Radiographs images will be taken at screening, weeks 6, 12, 24 and 52; CT-scans will be taken at weeks 24 and 52 post-op If the patient has a secondary surgical intervention (procedure that adjusts or in any way modifies or removes part of the original implant configuration) at any time after the 6 month visit, the next CT scan will not be necessary. Starting at week 12, all XR images will be weight bearing.
Interventions
- Device MagnetOs
MagnetOs will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint. - Other Autograft
In this study, the comparator is autograft and will be used at a volume of approximately 1-5 cc's for the TN, CC and ST joints, and up to 10 cc's for the tibiotalar joint.
Primary outcome measures
- Radiographic fusion by CT scan [Time frame: Week 24 post-op]
Secondary outcome measures (5)
- Radiographic fusion by CT scan [Time frame: Week 52]
- Radiographic Fusion by plain radiographs [Time frame: week 12, week 24, week 52 post-surgery]
- Functional [Time frame: Screening to Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery.]
- Functional [Time frame: Screening, Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery.]
- Functional [Time frame: Screening, Week 2, Week 6, Week 12, Week 24 and Week 52 post-surgery.]
Eligibility criteria
Inclusion:
- 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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Steadman Philippon Research Institute — Vail
- Hughston Foundation Inc — Columbus
- OrthoCarolina Research Institute, Inc — Charlotte
- Reconstructive Orthopaedic Associates II dba Rothman Orthopaedic Institute — Philadelphia
- Integrity Orthopedics and Sports Medicine — Chattanooga
- Centers for Advanced Orthopaedics — Falls Church
Identifiers
NCT: NCT07225751 · FA-2025-001