Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-16 @ 2:47 AM
Study NCT ID:
NCT02683460
Status:
UNKNOWN
Last Update Posted:
2016-02-17
First Post:
2016-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty
Sponsor:
The Catholic University of Korea
Organization:
Study Overview
Official Title:
Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
NOT_YET_RECRUITING
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 aims to compare the clinical results of patella resurfacing or not under subvastus approach in total knee arthroplasty. Even though the excellent results of total knee arthroplasty(TKA), there is persistent controversy over whether or not to replace the patella. Anterior knee pain continued to be a unsolved problem of TKA patients. Some surgeons always performed patella resurfacing during total knee arthroplasty but the others didn't do that. It's up to surgeon's preference. There were several studies of patellar resurfacing or not in TKA. But previous studies almost have been done under other approach, not a subvastus approach.
This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.
This study prospectively randomized patients receiving bilateral TKA with patellar resurfacing or not in each knee. Patients preference and clinical results was investigated in both knee of same patients who received patellar resurfacing or not during minimum 2 year follow up.
Detailed Description:
The primary objective of this work was to compare pain, stiffness and function between groups at minimum 2 year postoperatively. Secondarily, we compared pain, patient preference at minimum 2 year postoperatively. The investigators hypothesized that there would be no difference between the two groups of subjects in the measured outcomes.
Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index \[WOMAC\]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.
Patients receiving TKA were prospectively enrolled before surgery and randomized intraoperatively to either receive patella replacement or not in both knee of same patients. Subjects were assessed pre-operatively and at 6 months, 1, 2 years postoperatively for pain, function, and stiffness using a disease-specific (Western Ontario and McMaster Osteoarthritis Index \[WOMAC\]) . Other measurements like Knee Society score, Feller's score, Patient satisfaction (VAS) also checked pre-operatively and at 6 months, 1, 2 years postoperatively.
Study Oversight
Has Oversight DMC:
False
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?: