Ignite Creation Date:
2024-05-06 @ 12:46 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01656694
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2012-08-01
Brief Title:
A Single-Center Epidemiological Study of the Survivorship of the DePuy Sigma HP Unicompartmental Knee Prosthesis
Sponsor:
Mississippi Sports Medicine and Orthopaedic Center
Organization:
Mississippi Sports Medicine and Orthopaedic Center
Study Overview
Official Title:
Two and Five-Year Survivorship of Unicompartmental Knee Arthroplasty Using DePuy Sigma HP Replacement
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None