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

Sponsor
Exactech (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05691868
Collaborator
(none)
400
2
149.7
200
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)
    Actual Study Start Date :
    Apr 8, 2019
    Anticipated Primary Completion Date :
    Dec 31, 2030
    Anticipated Study Completion Date :
    Sep 30, 2031

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    4. 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

    5. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario de Canarias Santa Cruz De Tenerife Spain 38320
    2 SWISS ORTHO CENTER Pain Clinic Basel Basel Switzerland CH-4010

    Sponsors and Collaborators

    • Exactech

    Investigators

    • Principal Investigator: Victor Valderrabano, MD, PhD, SWISS ORTHO CENTER Pain Clinic Basel
    • Principal Investigator: Mario Herrera- Perez, MD, PhD, Hospital Universitario de Canarias

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Exactech
    ClinicalTrials.gov Identifier:
    NCT05691868
    Other Study ID Numbers:
    • CR16-004
    First Posted:
    Jan 20, 2023
    Last Update Posted:
    Jan 23, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 23, 2023