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:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01464632
Eligibility Criteria:
Inclusion Criteria:
* Meet the indications for use of the EPIK Uni-compartmental knee system
* Must be a primary surgery
* Have a primary diagnosis of OA in the medial knee compartment
* Have active and passive flexion \> 90º
* Have a fixed flexion contracture \< 10º
* Have an intact ACL and PCL
* Be a primary, unilateral surgery
* Have BMI ≤ 35.00
* Must not have infection (or history of infection within last 3 months), chronic or acute, local or systemic
* Must not be pregnant
* Be willing and able to sign the informed consent
* Be willing to follow study procedures, including all follow up visits
* Be over 18 years of age (≥ 18) and 60 years or younger (≤ 60) at time of consent
Exclusion Criteria:
* Prior total or uni-knee arthroplasty (must be a primary surgery)
* Patello-femoral joint symptoms
* Bilateral surgical procedures
* BMI \> 35.00
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Insufficient bone quality which may affect the stability of the implant
* Infection (or history of infection within last 3 months), chronic or acute, local or systemic
* Is younger than 18 years of age (\<18) or over 60 (\>60) years of age
* Mental conditions that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements
* High levels of physical activity (ex. Competitive sports, heavy physical labor)
* Documented (active) alcohol or drug addictions
* Loss of ligamentous structures
* Prisoner
* Metals sensitivity
* Subject is pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01464632
Study Brief:
Protocol Section:
NCT01464632