Comparative Study Between Patellar Denervation and Non-patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing

Study Overview
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Brief Summary
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The purpose of this study is to compare the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing

Official Title
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Patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing to Relieve Postoperative Anterior Knee Pain: a Randomized Control Trial

Conditions
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Patellar Denervation, Non-patellar Denervation, Patellar Resurfacing

Intervention / Treatment
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* Procedure: Total knee arthroplasty
* Procedure: Patellar denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty Exclusion Criteria: Valgus deformity History of inflammatory arthroplathy Previous fracture or open surgery on the same knee History of patellar instability
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 |
| --- | --- |
| Active Comparator: Patellar denervation<br> | Procedure: Total knee arthroplasty<br>* A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)<br>Procedure: Patellar denervation<br>* circumpatellar electrocautery with monopolar coagulation diathermy<br>|
| Experimental: Non-patellar denervation<br> | Procedure: Total knee arthroplasty<br>* A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of post-operative anterior knee pain | Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome | Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion of knee | degree of motion of the knee after surgery | Change from baseline range of motion of knee at 3 months, 6 months, and 12 months after surgery | 
| Knee Society and Knee Society function score | Knee Society and Knee Society function score (minimum 0, maximum 200) | Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery | 
| New patellar score (Bartlett score) | New patellar score or Bartlett score (minimum 0, maximum 30) | Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery | 
| Oxford knee score | Oxford knee score (minimum 0, maximum 48) | Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery | 
| patellar shift index | The estimation of patellar position relative to the trochear | Change from baseline 3 months, 6 months, and 12 months after surgery | 
| prevalence of anterior knee pain | Percent of anterior knee pain | Change from baseline prevalence of anterior knee pain at 3 months, 6 months, and 12 months after surgery | 
| activity of daily living | activity of daily living score (minimum 0, maximum 20) | Change from baseline activity of daily living at 3 months, 6 months, and 12 months after surgery | 
| post-operative complication | Number and type of post-operative complication | Number and type of post-operative complication at 3 months, 6 months, and 12 months after surgery |