Infection Rate 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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The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.

Detailed Description
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924 knees (462 participants) will prospectively be randomized into 2 groups: two surgeons bilateral TKA and single surgeon bilateral TKA. While 2 surgeons will perform simultaneous total knee arthroplasty in the two surgeons' bilateral TKA group, one surgeon will perform sequentially in the single surgeon bilateral TKA group. The primary outcome is to compare the incidence of PJI between the groups. Secondary, logistic regression use to estimate the effect of two surgeons bilateral TKA and single surgeon bilateral TKA on the likelihood of a patient being infected.

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

Conditions
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Infection Joint, Joint Infection, Arthroplasty Complications

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 without severe extra-articular deformities

Ages Eligible for Study
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Minimum Age: 18 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: Two surgeon bilateral TKA group<br>2 surgeons will perform simultaneous total knee arthroplasty in this group. | Procedure: Simultaneous bilateral total knee arthroplasty<br>* Two surgeon 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 |
| --- | --- | --- |
| Infection incedence | Early infection rates | 90 days |