Incidence of Patellar Crepitus in Removal and Non-removal of Fibrosynovial Tissue at Superior Pole of Patella

Study Overview
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Brief Summary
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The purpose of this study is to compare the incidence of patellar crepitus complication and the clinical outcome between remove and not remove fibrosynovial tissue at the border of the superior pole of the patellar in posterior stabilized total knee arthroplasty.

Official Title
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Prospective Randomized Controlled Trial: Comparison of Incidence of Patellar Crepitus Between Removal and Non-removal of Fibrosynovial Tissue at the Border of the Superior Pole of the Patellar

Conditions
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Removal of Fibrosynovial Tissue, Non-removal of Fibrosynovial Tissue, Patellar Non-resurfacing

Intervention / Treatment
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* Procedure: Removal of fibrosynovial tissue
* Procedure: Non-removal of fibrosynovial tissue


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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Removal of fibrosynovial tissue<br>Removal of fibrosynovial tissue in patellar non-resurfacing TKA | Procedure: Removal of fibrosynovial tissue<br>* Remove of fibrosynovial tissue at the superior border of patella<br>|
| Experimental: Non-removal of fibrosynovial tissue<br>Non-removal of fibrosynovial tissue in patellar non-resurfacing TKA | Procedure: Non-removal of fibrosynovial tissue<br>* Do not remove of fibrosynovial tissue at the superior border of patella<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of patellar crepitus complication | Incidence of patellar crepitus complication (present, absent) | Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | New patellar 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 | 
| 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 |