Clinical trial NCT05691868: Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Official title: An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Arthritis of Ankle
Failure, Prosthesis
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer

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

Primary outcomes:
measure: AOFAS
timeFrame: Through study completion, an average of 1 per year
measure: SMFA
timeFrame: Through study completion, an average of 1 per year
measure: SF-36
timeFrame: Through study completion, an average of 1 per year
measure: Sports Frequency Score
timeFrame: Through study completion, an average of 1 per year
measure: VAS Pain score and Patient Satisfaction
timeFrame: Through study completion, an average of 1 per year
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Basel
country: Switzerland
facility: SWISS ORTHO CENTER Pain Clinic Basel
Study officials:
affiliation: SWISS ORTHO CENTER Pain Clinic Basel
name: Victor Valderrabano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Canarias
name: Mario Herrera- Perez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: