Recruiting

Exactech Vantage

Sponsor:

Exactech

Code:

NCT05619588

Conditions

Ankle Rheumatoid Arthritis

Arthritis of Ankle

Failure, Prosthesis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Ankle Rheumatoid Arthritis

Arthritis of Ankle

Failure, Prosthesis

Study ID

NCT05619588

Start date

Apr 4, 2017

Status verified date

Feb, 2025

Completion date

Sep 30, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

370 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • AOFAS [ Time Frame: Through study completion, an average of 1 per year ]
  • SMFA [ Time Frame: Through study completion, an average of 1 per year ]
  • SF-36 [ Time Frame: Through study completion, an average of 1 per year ]
  • Sports Frequency Score [ Time Frame: Through study completion, an average of 1 per year ]
  • VAS Pain and Patient Satisfaction Score [ Time Frame: Through study completion, an average of 1 per year ]

Central Contacts and Locations

Central contacts

Rachael Craig

352-377-1140rachael.craig@exac.com

Sandrine Angibaud

352-377-1140sandrine.angibaud@exac.com

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Duke Department of Orthopaedic Surgery

Recruiting

Durham, North Carolina, United States, 27703

More Information

Sponsor

Exactech

Last update posted

Feb 27, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exactech on 2025-02-27.