Clinical trial NCT05619588: Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
Official title: An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Rheumatoid Arthritis
Arthritis of Ankle
Failure, Prosthesis
Lead sponsor: Exactech
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 370
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 Total Ankle 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 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

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 and Patient Satisfaction Score
timeFrame: Through study completion, an average of 1 per year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Durham
country: United States
facility: Duke Department of Orthopaedic Surgery
state: North Carolina
Study officials:
affiliation: Duke Department of Orthopaedic Surgery
name: Samuel Adams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Edward Haupt, MD
role: PRINCIPAL_INVESTIGATOR
References: