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

Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement

Sponsors

Lead Sponsor: Mississippi Sports Medicine and Orthopaedic Center

Collaborator: DePuy Orthopaedics

Source Mississippi Sports Medicine and Orthopaedic Center
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.

Overall Status Completed
Start Date August 2012
Completion Date December 2016
Primary Completion Date December 31, 2015
Study Type Observational
Primary Outcome
Measure Time Frame
Five-Year Survivorship Five Years Post-Op
Secondary Outcome
Measure Time Frame
Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship Two Years and Five Years Post-Op
Functional Outcomes Five Years Post-Op
Radiographic Outcomes Pre-Operatively, Two and Five-Year Post-Op
Adverse Advents Post-Operatively
Enrollment 300
Condition
Intervention

Intervention Type: Device

Intervention Name: DePuy Sigma HP Partial Knee

Eligibility

Sampling Method: Non-Probability Sample

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jeff D Almand, MD Principal Investigator Mississippi Sports Medicine and Orthopaedic Center
Location
Facility: Mississippi Sports Medicine and Orthopaedic Center
Location Countries

United States

Verification Date

March 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational Model: Cohort

Time Perspective: Other

Source: ClinicalTrials.gov