Actively Recruiting
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
Led by Exactech · Updated on 2025-02-27
370
Participants Needed
2
Research Sites
756 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 such as prior paralysis, fusion, 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
- Patient with previous ankle arthrodesis with excision of the malleoli
- Patient with excessive loads caused by activity or patient weight as per investigator discretion
- Skeletally immature patients (under 21 years of age at time of surgery)
- Patient with dementia
- Patient with known metal allergies
- Patient who is pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
2
Duke Department of Orthopaedic Surgery
Durham, North Carolina, United States, 27703
Actively Recruiting
Research Team
R
Rachael Craig
CONTACT
S
Sandrine Angibaud
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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