Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only (NCT05619588) | Clinical Trial Compass
RecruitingNot Applicable
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
United States370 participantsStarted 2017-04-04
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
AOFAS
Timeframe: Through study completion, an average of 1 per year
2
SMFA
Timeframe: Through study completion, an average of 1 per year
3
SF-36
Timeframe: Through study completion, an average of 1 per year
4
Sports Frequency Score
Timeframe: Through study completion, an average of 1 per year
5
VAS Pain and Patient Satisfaction Score
Timeframe: Through study completion, an average of 1 per year