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Compares treatment options for Ankle Arthrodesis or Arthroplasty
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.
ClinicalTrials.gov ID: NCT07225751
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Hardware parameters - rigid fixation using screws, plates, staples, nails or a combination. Exclusion:
See the full 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vail, Colorado, United States
- Columbus, Georgia, United States
- Charlotte, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Chattanooga, Tennessee, United States
- Falls Church, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vail, Colorado, United States; Columbus, Georgia, United States; Charlotte, North Carolina, United States; Philadelphia, Pennsylvania, United States; Chattanooga, Tennessee, United States; Falls Church, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.