A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis

Completed

Conditions studied: Osteoarthritis, Unicompartmental Knee Arthroscopy

In brief

This study will be conducted to assess the survivorship of a particular prosthesis used in unicompartmental knee arthroplasties. Patients undergoing this procedure have been diagnosed with isolated medial or lateral compartmental arthritis and have failed conservative treatment. The patients received a unicompartmental knee replacement using the Sigma® HP Partial Knee System.

Key facts

Study ID

NCT01656694

Run by

Mississippi Sports Medicine and Orthopaedic Center

People needed

300

Starts

2012-08-01

Expected to finish

2016-12-01

Last updated by the study team

2018-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mississippi Sports Medicine and Orthopaedic Center — Jackson, Mississippi, United States

Full record on ClinicalTrials.gov

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