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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Patella Resurfacing
• Intervention / Treatment: Procedure: Patella resurfacing; Procedure: Patella retention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale	Change from preoperative score to postoperative 2 years
Knee Society score	Change from preoperative score to postoperative 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 4, 2016
• First Submitted That Met QC Criteria: February 16, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: Patella resurfacing