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

Recruiting

• Conditions: Arthritis of Ankle; Rheumatoid Arthritis; Failure, Prosthesis

• Registration Number: NCT05691868
• Lead Sponsor: Exactech

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-08
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27
• Primary Completion: 2030-12-31
• Study Completion: 2031-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 visit requirements
• 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
• Pateint 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
• Previsous ankle arthrodesis with excision of the malleoli
• Excessive loads as cuased 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
• 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SMFA	Through study completion, an average of 1 per year	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
SF-36	Through study completion, an average of 1 per year	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
VAS Pain score and Patient Satisfaction	Through study completion, an average of 1 per year	Visual Analog Scale (VAS) Score - Range of scores from 0-100 to indicate level of pain - Higher score indicates greater pain intensity
Sports Frequency Score	Through study completion, an average of 1 per year	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
AOFAS	Through study completion, an average of 1 per year	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

Trial Locations

Locations (2)

SWISS ORTHO CENTER Pain Clinic Basel; 🇨🇭 Basel, Switzerland

Hospital Universitario de Canarias; 🇪🇸 Santa Cruz De Tenerife, Spain