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| Name | Class |
|---|---|
| DePuy Orthopaedics | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DePuy Sigma HP Partial Knee | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff D Almand, MD | Mississippi Sports Medicine and Orthopaedic Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mississippi Sports Medicine and Orthopaedic Center | Jackson | Mississippi | 39202 | United States |
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| Two Years and Five Years Post-Op |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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