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

NCT05691868 | Recruiting

• 1 other identifier: CR16-004
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

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.

Conditions

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 score and Patient Satisfaction

  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 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

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
• 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

Sponsors & Collaborators

• Exactech: lead

Study Sites (2)

Hospital Universitario de Canarias

Santa Cruz de Tenerife, 38320, Spain

RECRUITING

SWISS ORTHO CENTER Pain Clinic Basel

Basel, CH-4010, Switzerland

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Prosthesis Failure

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Victor Valderrabano, MD, PhD

  SWISS ORTHO CENTER Pain Clinic Basel

  PRINCIPAL INVESTIGATOR

• Mario Herrera- Perez, MD, PhD

  Hospital Universitario de Canarias

  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: January 11, 2023
• First Posted: January 20, 2023
• Study Start: April 8, 2019
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): September 30, 2031
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CH (1); ES (1)