A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis
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.
Unicompartmental Knee Arthroscopy
Device: DePuy Sigma HP Partial Knee
|Study Design:||Observational Model: Cohort|
|Official Title:||Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement|
- Five-Year Survivorship [ Time Frame: Five Years Post-Op ] [ Designated as safety issue: No ]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-Year Survivorship Alternately Defining Failure and Two-Year Survivorship [ Time Frame: Two Years and Five Years Post-Op ] [ Designated as safety issue: No ]
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 [ Time Frame: Five Years Post-Op ] [ Designated as safety issue: No ]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.
- Radiographic Outcomes [ Time Frame: Pre-Operatively, Two and Five-Year Post-Op ] [ Designated as safety issue: No ]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.
- Adverse Advents [ Time Frame: Post-Operatively ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656694
|United States, Mississippi|
|Mississippi Sports Medicine and Orthopaedic Center|
|Jackson, Mississippi, United States, 39202|
|Principal Investigator:||Jeff D Almand, MD||Mississippi Sports Medicine and Orthopaedic Center|