Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts

Official Title
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Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial

Conditions
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Complete Contact, Incomplete Contact

Intervention / Treatment
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* Procedure: Complete patellofemoral articular contact
* Procedure: Incomplete patellofemoral articular contact


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 Age 50-80 year Exclusion Criteria: Revision surgery Bilateral total knee arthroplasty History of patellar fracture History of patellar chondromalacia 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: Complete contact<br> | Procedure: Complete patellofemoral articular contact<br>* The patellofemoral condition is in constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.<br>|
| Active Comparator: Incomplete contact<br> | Procedure: Incomplete patellofemoral articular contact<br>* The patellofemoral condition is in no constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee range of motion (ROM) | Goniometer measure range of motion (minimum 0, maximum 145) | Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery | 
| Knee flexion | Goniometer measure knee flexion (minimum 135, maximum 145) | Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery | 
| Knee extension | Goniometer measure knee extension (minimum -10, maximum 0) | Change from baseline knee extension at 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 | 
| Prevalence of anterior knee pain ,AKP | Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10) | Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery |