Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study

Study Overview
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Brief Summary
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Many surgeons and patients prefer bilateral total knee arthroplasty (TKA) under one anesthesia as single-stage administration. A single-stage bilateral TKA can be performed in two different ways: single-stage, two-team simultaneous bilateral TKA (two surgeons bilateral TKA), and single-stage, a sequential bilateral TKA (single surgeon bilateral TKA). The purpose of this study is to evaluate the radiological results in the single-stage bilateral TKA in terms of two surgeons bilateral TKA and single surgeon bilateral TKA.

Detailed Description
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Investigators will enroll 136 participants with primary bilateral symptomatic knee osteoarthritis that will refractory to conservative treatment who will undergo bilateral TKA under single anaesthesia after 15.06.2020. Investigators will include patients who were less than 75 years old, with no history of malignancy, without severe extra-articular deformities, and without the systemic inflammatory disease, severe cardiac insufficiency, and morbid obesity (>40 kg/m2 or 35 or more and experiencing obesity-related health conditions). An informed consent form will be obtained from all patients.

Official Title
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Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study

Conditions
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Gonarthrosis; Primary

Intervention / Treatment
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* Procedure: Simultaneous bilateral total knee arthroplasty
* Procedure: Sequenced bilateral TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary bilateral knee osteoarthritis with refractory to conservative treatment Patients who accept participation in the research and the randomization Exclusion Criteria: no history of malignancy less than 75 years old without severe extra-articular deformities severe cardiac insufficiency and morbid obesity without systemic inflammatory diseases

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simultaneous<br>2 surgeons will perform simultaneous total knee arthroplasty in this group. | Procedure: Simultaneous bilateral total knee arthroplasty<br>* Two surgeons bilateral TKA group<br>|
| Active Comparator: Single surgeon bilateral TKA group<br>One surgeon will perform sequentially tptal knee arthroplasty in this group | Procedure: Sequenced bilateral TKA<br>* Single surgeon bilateral TKA group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological examination | Coronal and Sagittal Alignment | 14days |