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

Mississippi Sports Medicine and Orthopaedic Center

Status: Completed

Conditions: Osteoarthritis; Unicompartmental Knee Arthroscopy

Treatments: Device: DePuy Sigma HP Partial Knee

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01656694

11018

Details and patient eligibility

About

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.

Full description

This study is an epidemiological Level IV-Case Series clinical study that will study the survivorship of the Sigma® HP Partial Knee System in a consecutive series of patients. All patients who received the Sigma® HP Partial Knee System between August 21, 2008 and October 31, 2009 will be available to include in the study. Data will be collected preoperatively, intra-operatively, and post-operatively at intervals of 6 weeks, 6 months, 1 year, 2 years, and 5 years. Data will be analyzed for survivorship status at the 2- and 5-year follow-up visits. Other data, including functional outcomes, radiographic outcomes, and wear will be analyzed at the 5-year follow-up visit. Subjects will participate in the study for five years after their surgery.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.