Recruiting NCT05691868
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis. Basic parameters: from 21 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
- Spain, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)
Overview
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.
Primary outcome measures
- AOFAS [Time frame: Through study completion, an average of 1 per year]
- SMFA [Time frame: Through study completion, an average of 1 per year]
- SF-36 [Time frame: Through study completion, an average of 1 per year]
- Sports Frequency Score [Time frame: Through study completion, an average of 1 per year]
- VAS Pain score and Patient Satisfaction [Time frame: Through study completion, an average of 1 per year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Universitario de Canarias — Santa Cruz de Tenerife
Switzerland · 1 center
- SWISS ORTHO CENTER Pain Clinic Basel — Basel
Identifiers
NCT: NCT05691868 · CR16-004