Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT03142958
Eligibility Criteria:
Inclusion Criteria:
* The patient is skeletally mature.
* The patient qualifies for primary Total Ankle Replacement (TAR) per the surgeon and has a diagnosis of one of the following: Primary Arthritis (e.g. Degenerative Disease), Secondary Arthritis (e.g. Post-Traumatic, Avascular Necrosis, if minimally 2/3 of the talus is preserved), or Systemic Arthritis of the ankle (e.g. Rheumatoid Arthritis, Hemochromatosis).
* The patient is willing and able to complete scheduled follow-up visits, evaluations and questionnaires as described in the Informed Consent.
* The patient reads, understands and signs the Institutional Review Board (IRB) approved Informed Consent.
Exclusion Criteria:
* The patient is Morbidly Obese (defined by Body Mass Index (BMI) \> 40 or BMI of 35 - 40 with significant medical problems caused by or made worse by their weight).
* The patient has one of the following conditions, which could compromise the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological (Charcot's Arthropathy) or vascular disease, loss of musculature or neuromuscular compromise.
* The patient has an active local/systemic infection that may affect the prosthetic joint or has a recent history of infection.
* The patient has a condition that may impair proper wound healing (e.g., poor soft tissue envelope).
* The patient is pregnant or plans to become pregnant during the follow up period.
* The patient has a metabolic disorder or disease that may compromise bone quality (e.g. arthrogryposis etc.), physiological or anatomical anomalies, and/or malignancy/local bone tumors.
* The patient has inadequate neuromuscular status (e.g., prior paralysis, severe neuropathy).
* The patient has a known sensitivity or allergic reaction to one or more of the implanted materials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03142958
Study Brief:
Protocol Section:
NCT03142958