NCT05619588 Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
| NCT ID | NCT05619588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Exactech |
| Condition | Ankle Rheumatoid Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 370 participants |
| Start Date | 2017-04-04 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 370 participants in total. It began in 2017-04-04 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle System. This study will follow subjects for a period of up to 10 years post-surgery.
Eligibility Criteria
Inclusion Criteria: * Patient is indicated for total ankle arthroplasty * Patient is skeletally mature * Patient is mentally capable of completing follow-up forms * Patient will be available for follow-up out to 10 years * Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator * Patient is willing and able to read and sign a study informed consent form Exclusion Criteria: * Patient with excessive bone loss at the ankle joint site * Patient with severe osteoporosis * Patient with complete talar avascular necrosis * Patient with Active Osteomyelitis * Patient with Infection at the ankle site or infection at distant sites that could migrate to the ankle * Patient with Sepsis * Patient with Vascular deficiency in the involved limb * Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength) * Patient with Neuropathic joints * Patient with Neurological or musculoskeletal disease or loss of function that may adversely affect movement of the lower limb, gait, or weight bearing * Patient with Poor soft tissue coverage around the ankle * Patient with Charcot arthropathy * Previous ankle arthrodesis with excision of the malleoli * Excessive loads as caused by activity or patient weight - per investigator discretion * Skeletally immature patients (patient is less than 21 years if age at time of surgery) * Patient with dementia * Patient with known metal allergies * Patient who is pregnant
Contact & Investigator
Samuel Adams, MD
PRINCIPAL INVESTIGATOR
Duke Department of Orthopaedic Surgery
Frequently Asked Questions
Who can join the NCT05619588 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Ankle Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05619588 currently recruiting?
Yes, NCT05619588 is actively recruiting participants. Contact the research team at rachael.craig@exac.com for enrollment information.
Where is the NCT05619588 trial being conducted?
This trial is being conducted at Jacksonville, United States, Durham, United States.
Who is sponsoring the NCT05619588 clinical trial?
NCT05619588 is sponsored by Exactech. The principal investigator is Samuel Adams, MD at Duke Department of Orthopaedic Surgery. The trial plans to enroll 370 participants.
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