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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT01656694
Eligibility Criteria:
Inclusion Criteria:
* Adult patient over the age of 18
* Diagnosis of isolated medial or lateral compartmental osteoarthritis of the knee joint
* Must have failed conservative treatment and received a unicompartmental knee arthroplasty between August 21, 2008 and October 31, 2009.
* Must have received the Sigma® HP Partial Knee System.
* Must have received the surgery from Dr. Almand, Dr. Johnson, or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
* Must be willing to provide written consent to participate in the study.
* Subjects who do not have the legal capacity to consent may be enrolled in the study by a Legally Authorized Representative (LAR). The LAR must provide verification that they have the legal authority to represent the subject.
Exclusion Criteria:
* Did not receive a unicompartmental knee arthroplasty between August 21, 2008 and October 31, 2009.
* Did not receive a unicompartmental knee arthroplasty using the Sigma® HP Partial Knee.
* Did not receive their unicompartmental knee replacement from Dr. Almand, Dr. Johnson, or Dr. Pickering at Mississippi Sports Medicine and Orthopaedic Center.
* Subjects lost to follow-up for any reason including, but not limited to: refusal to consent, death, or geographic isolation will also be excluded from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01656694
Study Brief:
Protocol Section:
NCT01656694