A Single-Center, Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis
This trial is active, not recruiting.
|Conditions||osteoarthritis, unicompartmental knee arthroscopy|
|Treatment||depuy sigma hp partial knee|
|Sponsor||Mississippi Sports Medicine and Orthopaedic Center|
|Start date||August 2012|
|End date||December 2015|
|Trial size||300 participants|
|Trial identifier||NCT01656694, 11018|
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.
time frame: Five Years Post-Op
Five-Year Survivorship Alternately Defining Failure and Two-Year Survivorship
time frame: Two Years and Five Years Post-Op
time frame: Five Years Post-Op
time frame: Pre-Operatively, Two and Five-Year Post-Op
time frame: Post-Operatively
Male or female participants at least 18 years old.
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.
|Official title||Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement|
|Principal investigator||Jeff D Almand, MD|
|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.|
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