Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty
|ClinicalTrials.gov Identifier: NCT02683460|
Recruitment Status : Unknown
Verified February 2016 by Yong In, The Catholic University of Korea.
Recruitment status was: Not yet recruiting
First Posted : February 17, 2016
Last Update Posted : February 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Patella Resurfacing||Procedure: Patella resurfacing Procedure: Patella retention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2017|
Experimental: patella resurfacing group
Procedure: Patellar component Resurfacing with onlay technique
Procedure: Patella resurfacing
Active Comparator: patella retention
Procedure: patellar retention Trimming of osteophytes when appropriate
Procedure: Patella retention
- WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale [ Time Frame: Change from preoperative score to postoperative 2 years ]
- Knee Society score [ Time Frame: Change from preoperative score to postoperative 2 years ]
- Feller's score [ Time Frame: Change from preoperative score to postoperative 2 years ]
- Patients satisfaction using Visual Analog Score for pain [ Time Frame: Change from preoperative score to postoperative 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683460
|Contact: Yong In, MD, PhDfirstname.lastname@example.org|
|Contact: Mansoo Kim, MDemail@example.com|
|Study Chair:||Yong In, MD, PhD||the Catholic Univerisity of Korea Seoul St Mary's hospital|