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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656694
• Other study ID #: 11018
• Status: Completed
• First received: August 1, 2012
• Last updated: March 20, 2018
• Start date: August 2012
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Mississippi Sports Medicine and Orthopaedic Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Unicompartmental Knee Arthroscopy

Intervention

Device:
• DePuy Sigma HP Partial Knee

Locations

Country	Name	City	State
United States	Mississippi Sports Medicine and Orthopaedic Center	Jackson	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Mississippi Sports Medicine and Orthopaedic Center	DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Five-Year Survivorship	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.	Five Years Post-Op
Secondary	Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship	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.	Two Years and Five Years Post-Op
Secondary	Functional Outcomes	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.	Five Years Post-Op
Secondary	Radiographic Outcomes	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.	Pre-Operatively, Two and Five-Year Post-Op
Secondary	Adverse Advents	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.	Post-Operatively