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Clinical Trials/NCT02683460
NCT02683460
Unknown
Not Applicable

Comparison of Clinical Results of Patella Resurfacing Versus Patellar Retention Under Subvastus Approach in Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial

The Catholic University of Korea0 sites100 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Patella Resurfacing
Sponsor
The Catholic University of Korea
Enrollment
100
Primary Endpoint
Knee Society score
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
December 2017
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yong In

Professor

The Catholic University of Korea

Eligibility Criteria

Inclusion Criteria

  • Patients for total knee arthroplasty
  • Having medicare insurance

Exclusion Criteria

  • Patients who are not able to cooperate
  • Serious deformity (not suitable for a standard TKA prosthesis)
  • Patellar thickness less than 18 mm
  • Prior operation involving the extensor mechanism
  • Rheumatoid arthritis
  • Severe medical disability limiting the ability to walk
  • Revision surgery
  • Knees with predominantly patellofemoral arthrosis

Outcomes

Primary Outcomes

Knee Society score

Time Frame: Change from preoperative score to postoperative 2 years

WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale

Time Frame: Change from preoperative score to postoperative 2 years

Secondary Outcomes

  • Feller's score(Change from preoperative score to postoperative 2 years)
  • Patients satisfaction using Visual Analog Score for pain(Change from preoperative score to postoperative 2 years)

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