Clinical Trials Directory

Trials / Unknown

UnknownNCT02683460

Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty

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
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
The Catholic University of Korea · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPatella resurfacing
PROCEDUREPatella retention

Timeline

Start date
2016-02-01
Primary completion
2017-12-01
First posted
2016-02-17
Last updated
2016-02-17

Source: ClinicalTrials.gov record NCT02683460. Inclusion in this directory is not an endorsement.