Patellar Resurfacing Under Subvastus Approach in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoarthritis, Patella Resurfacing

Intervention / Treatment
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* Procedure: Patella resurfacing
* Procedure: Patella retention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patella resurfacing group<br>Procedure: Patellar component Resurfacing with onlay technique | Procedure: Patella resurfacing<br> <br> |
| Active Comparator: patella retention<br>Procedure: patellar retention Trimming of osteophytes when appropriate | Procedure: Patella retention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |