Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)

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

Phase

N/A

Condition

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT05691868
CR16-004
  • Ages > 21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 visitrequirements

  • 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

  • Pateint 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

  • Previsous ankle arthrodesis with excision of the malleoli

  • Excessive loads as cuased 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

  • 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

Study Design

Total Participants: 400
Study Start date:
April 08, 2019
Estimated Completion Date:
September 30, 2031

Connect with a study center

  • Hospital Universitario de Canarias

    Santa Cruz De Tenerife, 38320
    Spain

    Active - Recruiting

  • SWISS ORTHO CENTER Pain Clinic Basel

    Basel, CH-4010
    Switzerland

    Active - Recruiting

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