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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, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27703