Partial Synovectomy in Articular Side of Quadriceps Tendon Verified to Reduce Crepitus in Retrospective Study

Study Overview
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Brief Summary
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Crepitus causing unsatisfied result to patients after posterior stabilized total knee arthroplasty. Recent retrospective study demonstrated removal of hyperplastic synovium in distal quadriceps caused reduce of crepitus. However, this study has limitation of time gap exist between arms, different in observation time and bias caused by retrospective review. Thus aim of this study is that by randomized trial, verified hyperplastic synovium in distal quadriceps causing crepitus. Target enrolled patients in this study are scheduled to perform both total knee arthroplasty. Experimental group is randomized side (right or left) of knee, and control group is other side of knee. Both arms decided by randomized number table. Crepitus measured after 3mo, 6mo, 1year after surgical treatment

Detailed Description
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Surgical treatment of TKA with synovium removal in distal quadriceps tendon performed classifed as experimental arm and TKA wiout synovium removal classified as control arm. Before surgical treatment, radiologic and physiological evaluation performed to check too much variance shown in either arm. Radiologic parameter include Hip knee ankle angle, Femoral tibial angle, Level of joint line, Insall-Salvati ratio, Posterior tibial slope, Posterior femoral condylar offset, Patellar thickness, Patellar tilt, Patellar displacement. During surgical treatment patella resurfacing in either group excluded this study. Indication of patella resufacing is ICRS grade IV in lateral surface of patella. After surgical procedure done check grade of crepitus (0-no crepitation, 1-fine crepitation, 2-coarse crepitation) with WOMAC, Knee Society Score, Eq-5D (European quality of life -5 Dimensions), Forgotten joint score after 3month, 6month and 1year after surgical procedure. Other collecting variance Age, Gender, BMI, Range of motion of knee, Fmoeral/Tibial component size, PE thickness

Official Title
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Partial Synovectomy in Articular Side of Quadriceps Tendon Reduces Crepitus After Posterior Stabilized Total Knee Arthroplasty : a Randomized, Controlled Trial

Conditions
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Osteoarthritis, Knee, Rheumatoid Arthritis, Knee, Spontaneous Osteonecrosis of Knee

Intervention / Treatment
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* Procedure: Prepectoral
* Procedure: Subpectoral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Patients who scheduled to perform both total knee arthroplasty(TKA) using posteiror crucitate sustain type (PS) Exclusion Criteria: Lost follow up (Including death of patient) Unexpected complication (e.g) Infection, periprosthetic fracture) Patella resurfacing Canceled surgical treatment Refused to enrolled study Too much radiological or physicological variance shown between either knee

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Synovium removal group<br> | Procedure: Prepectoral<br>* Remove all visible synovium in suprapatellar area under distal quadriceps tendon. All other procedures (Total Knee arthroplasty) are same with no intervention arm.<br>Procedure: Subpectoral<br>* No remove any synovium in suparapatellar area under distal quadriceps tendon. All other preocedures are same with experimental arm.<br>|
| No Intervention: Synovium sustain group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crepitus grade | Crepitus grade divided 3 categories ; 0-no crepitus, 1-asymptomatic crepitus, 2-Painful crepitus | 3month, 6month, 1year after surgical treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip knee ankle angle | Identify postop alignment of lower extrimities, which is mechanical axis between femur and tibia in scanogram of low extremity. | 3month, 6month, 1year after surgical treatment | 
| Insall-Salvati ratio | Measured in true lateral position in 30' knee flextion, measureing patellar position in lateral plain radiograph of knee. | 3month, 6month, 1year after surgical treatment | 
| Patellar displacement | Measuring patellar position in merchant view of plain radiograph. | 3month, 6month, 1year after surgical treatment | 
| Patellar tilt angle | Measuring patellar position in merchant view of plain radiograph. | 3month, 6month, 1year after surgical treatment | 
| Tibia offset | Estimate tibial component position in lateral plain radiograph. | 3month, 6month, 1year after surgical treatment | 
| Knee society score | Clinical score evaluate functional ability of patients after surgery (0-100; high value represent better outcome) | 3month, 6month, 1year after surgical treatment | 
| WOMAC score | Clinical score evaluate pain, stiffness, function of knee after surgery (0-96; low value represent better outcome) | 3month, 6month, 1year after surgical treatment | 
| Forgotten joint score | Clinical score evaluate functional outcome after surgery (0-100; low value represent better outcome) | 3month, 6month, 1year after surgical treatment |