- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01656694
A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis
March 20, 2018 updated by: Mississippi Sports Medicine and Orthopaedic Center
Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Mississippi
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Jackson, Mississippi, United States, 39202
- Mississippi Sports Medicine and Orthopaedic Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Since the first Sigma® HP Partial Knee System was introduced at MSMOC, over 1,000 have been implanted in patients by the investigators of this study.
The population used for this study was the first patients of our clinic to receive this particular prosthesis.
The first replacement was implanted on August 21, 2008.
By October 31, 2009, 300 patients had received the Sigma® HP replacement.
These 300 patients will be the subject population whose data will be analyzed for the study upon their consent.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Five-Year Survivorship
Time Frame: Five Years Post-Op
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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.
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Five Years Post-Op
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship
Time Frame: 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. |
Two Years and Five Years Post-Op
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Functional Outcomes
Time Frame: 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.
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Five Years Post-Op
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Radiographic Outcomes
Time Frame: Pre-Operatively, Two and Five-Year Post-Op
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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.
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Pre-Operatively, Two and Five-Year Post-Op
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Adverse Advents
Time Frame: Post-Operatively
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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.
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Post-Operatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jeff D Almand, MD, Mississippi Sports Medicine and Orthopaedic Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
December 31, 2015
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
August 1, 2012
First Submitted That Met QC Criteria
August 1, 2012
First Posted (Estimate)
August 3, 2012
Study Record Updates
Last Update Posted (Actual)
March 22, 2018
Last Update Submitted That Met QC Criteria
March 20, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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