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

NCT ID: NCT01656694

Last Updated: 2018-03-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-12-31

Brief Summary

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.

Detailed 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.

Conditions

Osteoarthritis; Unicompartmental Knee Arthroscopy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

DePuy Sigma HP Partial Knee

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Mississippi Sports Medicine and Orthopaedic Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff D Almand, MD

Role: PRINCIPAL_INVESTIGATOR

Mississippi Sports Medicine and Orthopaedic Center

Locations

Mississippi Sports Medicine and Orthopaedic Center

Jackson, Mississippi, United States

Countries

United States

Other Identifiers

11018

Identifier Type: -

Identifier Source: org_study_id