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

Completed

• Conditions: Osteoarthritis; Unicompartmental Knee Arthroscopy

• Registration Number: NCT01656694
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-03
• Primary Completion: 2015-12-31
• Study Completion: 2016-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Five-Year Survivorship	Five Years Post-Op	The primary endpoint of the study is to determine the five-year survivorship of the Sigma® HP Partial Knee System with failure defined as revision for any reason.

Secondary Outcome Measures

Name	Time	Method
Radiographic Outcomes	Pre-Operatively, Two and Five-Year Post-Op	Another secondary endpoint of the study is to determine the radiographic outcomes based upon the radiographic assessment using the Knee Society scoring system, reported as changes from the pre-operative assessment. Additionally, we want to radiographically assess lucencies at the bone cement and implant cement interface to measure wear and loosening of the prosthesis.
Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship	Two Years and Five Years Post-Op	One secondary endpoint of the study is to determine the five-year survivorship of the prosthesis with alternately defining failure as: failure of implant, failure secondary to infection, failure secondary to progression of arthritis, failure secondary to periprosthetic fracture.; We also want to determine the two-year survivorship with failure defined as revision for any reason.
Functional Outcomes	Five Years Post-Op	Another secondary endpoint of the study is to analyze the functional outcomes for five-year data based on the Knee Society score and the KOOS (Knee Injury and Osteoarthritis Outcome Score) score, reported as changes from the pre-operative score. By using both rating systems, an appropriate evaluation of the functional outcome of the surgery should be obtained.
Adverse Advents	Post-Operatively	We also want to examine the type and frequency of adverse events as a secondary endpoint of the study. Safety will be evaluated with summary of adverse events.

Trial Locations

Locations (1)

Mississippi Sports Medicine and Orthopaedic Center; 🇺🇸 Jackson, Mississippi, United States