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NCT Number: NCT05691868

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis of Ankle Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Failure, Prosthesis Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. AOFAS

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rachael Craig

CONTACT

[email protected]

352-377-1140

Sandrine Angibaud

CONTACT

[email protected]

352-377-1140

Sponsors and collaborators

Lead sponsor

Exactech

Industry

Registry information

Official study title

An Open Label, Multi-Center, Single Arm Prospective Evaluation of Exactech Vantage Total Ankle System (Outside US)

Important dates

Study start
2019
Primary completion
2030
Study completion
2031
First posted
Jan 20, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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