RECRUITING

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

Conditions

Ankle Rheumatoid Arthritis Arthritis of Ankle Failure, Prosthesis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objectives of this study are to evaluate the performance and safety of the Vantage Total Ankle System. This study will follow subjects for a period of up to 10 years post-surgery.

Official Title

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

Quick Facts

Study Start:2017-04-04

Study Completion:2031-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05619588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patient is indicated for total ankle arthroplasty * Patient is skeletally mature * Patient is mentally capable of completing follow-up forms * Patient will be available for follow-up out to 10 years * Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator * Patient is willing and able to read and sign a study informed consent form	* 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 * Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength) * Patient 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 * Previous ankle arthrodesis with excision of the malleoli * Excessive loads as caused 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 * Patient who is pregnant

Inclusion Criteria

Exclusion Criteria

* Patient is indicated for total ankle arthroplasty
* Patient is skeletally mature
* Patient is mentally capable of completing follow-up forms
* Patient will be available for follow-up out to 10 years
* Patient has been deemed a candidate for Ankle replacement by diagnosis of the investigator
* Patient is willing and able to read and sign a study informed consent form

* 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
* Patient with Neuromuscular inadequacy (e.g. Prior paralysis, fusion and or inadequate abductor strength)
* Patient 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
* Previous ankle arthrodesis with excision of the malleoli
* Excessive loads as caused 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
* Patient who is pregnant

Contacts and Locations

Study Contact

Rachael Craig

CONTACT

352-377-1140

rachael.craig@exac.com

Sandrine Angibaud

CONTACT

352-377-1140

sandrine.angibaud@exac.com

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27703

United States

Collaborators and Investigators

Sponsor: Exactech

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-04-04

Study Completion Date2031-09-30

Study Record Updates

Study Start Date2017-04-04

Study Completion Date2031-09-30

Terms related to this study

Additional Relevant MeSH Terms

Ankle Rheumatoid Arthritis
Arthritis of Ankle
Failure, Prosthesis