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NCT05619588 | RECRUITING | Ankle Rheumatoid Arthritis

Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only
Sponsor:

Exactech

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.

Condition or disease

Ankle Rheumatoid Arthritis

Arthritis of Ankle

Failure, Prosthesis

Study Type : OBSERVATIONAL
Estimated Enrollment : 370 participants
Official Title : An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System
Actual Study Start Date : 2017-04-04
Estimated Primary Completion Date : 2030-12-31
Estimated Study Completion Date : 2031-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Exactech Vantage Total Ankle System Post Market Clinical Follow-Up - US Only

Location Details

NCT05619588

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Mayo Clinic

Jacksonville, Florida, United States, 32224

RECRUITING

United States, North Carolina

Duke Department of Orthopaedic Surgery

Durham, North Carolina, United States, 27703