Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)

Recruiting now

Conditions studied: Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis

In brief

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.

Key facts

Study ID

NCT05691868

Run by

Exactech

People needed

400

Starts

2019-04-08

Expected to finish

2031-09-30

Last updated by the study team

2025-02-27

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital Universitario de Canarias — Santa Cruz de Tenerife, Spain (enrolling)
• SWISS ORTHO CENTER Pain Clinic Basel — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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