Cemented vs Cementless in Bilateral TKA

Study Overview
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Brief Summary
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To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.

Detailed Description
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To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.

Official Title
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Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial

Conditions
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Osteoarthritis, Total Knee Arthroplasty

Intervention / Treatment
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* Device: Triathlon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA status 1 or 2 Diagnosed with bilateral osteoarthritis of the knees Participant understand and consent to the protocol of the trial Exclusion Criteria: Morbid obesity (BMI >40) Inflammatory arthritis Osteoporosis Metabolic bone disease Bone defect that seen from radiographs

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Cemented TKA<br>Cemented TKA (Triathlon, Stryker) include patellar resurfacing | Device: Triathlon<br>* Modern TKA design (Triathlon) with patellar resurfacing<br>|
| Experimental: Cementless TKA<br>Cementless TKA (Triathlon Tritanium, Stryker) include patellar resurfacing | Device: Triathlon<br>* Modern TKA design (Triathlon) with patellar resurfacing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare mean Forgotten joint score between 2 groups | The total score ranges from 0-100, where a high score is the best outcome | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | intra-operative assessment | 
| modified the Western Ontario and McMaster Universities Osteoarthritis Index score | The total score ranges from 0-96, where a high score is the worse outcome | post-op 2, 6 week, 3, 6, 12 month | 
| Pain level | VAS for pain (0-100) | Once daily 1-14 days after surgery then once a week until 3 months | 
| Range of knee motion | flexion and extension (degrees) which measured by long goniometer | post-op 2, 6 week, 3, 6, 12 month | 
| complication | such as fracture, infection, stiffness | until 1 year after surgery | 
| Radiological finding | Radiolucent line at femoral, tibial and patellar components which measured from radiolucent intervals (measured in millimetres) between the cement or prostheses and the bone according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system | post-op 2, 6 week, 3, 6, 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cemented, cementless, total knee arthroplasty, short term outcome, functional outcome