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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-08

Study Completion Date

2031-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05619588

Ankle Rheumatoid Arthritis Arthritis of Ankle Failure, Prosthesis

RECRUITING

Exactech Knee Systems Post Market Clinical Follow-up

NCT07107581

Knee Arthroplasty, Total Partial Knee Replacement

ENROLLING_BY_INVITATION

A Clinical Investigation of the Balance® Microplasty™ Hip System

NCT00699088

Osteoarthritis, Hip Rheumatoid Arthritis Avascular Necrosis

COMPLETED

Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study

NCT01308515

Osteoarthritis Degenerative Arthritis

WITHDRAWN NA

Mobile - Bearing Knee Study

NCT00765362

Inflammatory Tissue Disorder Osteoarthritis Avascular Necrosis +2 more

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis Arthritis of Ankle Failure, Prosthesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No