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

Last updated: February 26, 2025
Sponsor: Exactech
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT05619588
CR16-002
  • Ages > 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theinvestigator

  • Patient is willing and able to read and sign a study informed consent form

Exclusion

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 couldmigrate to the ankle

  • Patient with Sepsis

  • Patient with Vascular deficiency in the involved limb

  • Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and orinadequate abductor strength)

  • Patient with Neuropathic joints

  • Patient with Neurological or musculoskeletal disease or loss of function that mayadversely 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 investigatordiscretion

  • Skeletally immature patients (patient is less than 21 years if age at time ofsurgery)

  • Patient with dementia

  • Patient with known metal allergies

  • Patient who is pregnant

Study Design

Total Participants: 370
Study Start date:
April 04, 2017
Estimated Completion Date:
September 30, 2031

Connect with a study center

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Duke Department of Orthopaedic Surgery

    Durham, North Carolina 27703
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27703
    United States

    Active - Recruiting

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