NCT05691868 Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
| NCT ID | NCT05691868 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Exactech |
| Condition | Rheumatoid Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2019-04-08 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 400 participants in total. It began in 2019-04-08 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 Mobile-Bearing Total Angle 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 at least 21 years of age * Patient is likely to be available for follow-up out to 10 years * Patient is willing to participate by complying with pre- and postoperative visit requirements * 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 * Pateint 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 * Previsous ankle arthrodesis with excision of the malleoli * Excessive loads as cuased 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 * Patients who are unwilling to provide informed consent * Patients who are unlikely to be available for follow-up out to 10 years * Patients who are not deemed suitable candidates for the subject device * Patient is pregnant
Contact & Investigator
Victor Valderrabano, MD, PhD
PRINCIPAL INVESTIGATOR
SWISS ORTHO CENTER Pain Clinic Basel
Frequently Asked Questions
Who can join the NCT05691868 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying 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 NCT05691868 currently recruiting?
Yes, NCT05691868 is actively recruiting participants. Contact the research team at rachael.craig@exac.com for enrollment information.
Where is the NCT05691868 trial being conducted?
This trial is being conducted at Santa Cruz de Tenerife, Spain, Basel, Switzerland.
Who is sponsoring the NCT05691868 clinical trial?
NCT05691868 is sponsored by Exactech. The principal investigator is Victor Valderrabano, MD, PhD at SWISS ORTHO CENTER Pain Clinic Basel. The trial plans to enroll 400 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.