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

NCT05619588 | Recruiting

• 1 other identifier: CR16-002
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (5)

• AOFAS

  American Orthopedic Foot and Ankle Society Score (AOFAS) - Questionaire on pain (40 points), function (45 points) , and alignment (15 points) - 100 points score where 100 indicates a healthy midfoot

  Through study completion, an average of 1 per year

• SMFA

  Short Musculoskeletal Function Assessment (SMFA) Score - 46 items Patient questionnaire divided into two sections: 34 questions on patients function assessment and 12 questions covering how bothered patients are by their symptoms where 1 indicates no problems/no difficulty/ not bothered and 5 indicates unable to do/symptoms all the time/being greatly bothered

  Through study completion, an average of 1 per year

• SF-36

  Short Form Health Survey (SF-36) Score - 36-item patient-reproted survey of patient health - It consists on 8 scales: Physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each scale is transformed into a 0-100 scale where the lower score indicates the more disability and the higher score the lest disability

  Through study completion, an average of 1 per year

• Sports Frequency Score

  Sports Frequency Score - Level of sport activity in leisure time where 0 indicates "no sports activity" and 4 indicates "professional level of sports activity, elite athlete

  Through study completion, an average of 1 per year

• VAS Pain and Patient Satisfaction Score

  Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity

  Through study completion, an average of 1 per year

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Exactech: lead

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Duke Department of Orthopaedic Surgery

Durham, North Carolina, 27703, United States

RECRUITING

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel Adams, MD

  Duke Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

• Edward Haupt, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachael Craig

CONTACT

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

Sandrine Angibaud

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 17, 2022
• Study Start: April 4, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): September 30, 2031
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

US (2)