RECRUITINGOBSERVATIONAL
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Locations (2)
Mayo Clinic
Jacksonville, Florida, United States
Duke Department of Orthopaedic Surgery
Durham, North Carolina, United States