Actively Recruiting
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Led by Exactech · Updated on 2025-02-27
400
Participants Needed
2
Research Sites
651 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 Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.
CONDITIONS
Official Title
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
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
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain, 38320
Actively Recruiting
2
SWISS ORTHO CENTER Pain Clinic Basel
Basel, Switzerland, CH-4010
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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