Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion 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.

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.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05619588
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Exactech
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Ankle Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27703

Site Contact

Amanda Roberston

[email protected]

919-584-9493

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