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

Not Applicable

• Conditions: Gonarthrosis; Primary
• Interventions: Procedure: Simultaneous bilateral total knee arthroplasty; Procedure: Sequenced bilateral TKA

• Registration Number: NCT04434690
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-13
• Study First Submitted QC: 2020-06-13
• Last Update Submitted: 2020-06-13
• Study First Posted: 2020-06-17
• Last Update Posted: 2020-06-17
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simultaneous	Simultaneous bilateral total knee arthroplasty	2 surgeons will perform simultaneous total knee arthroplasty in this group.
Single surgeon bilateral TKA group	Sequenced bilateral TKA	One surgeon will perform sequentially tptal knee arthroplasty in this group

Primary Outcome Measures

Name	Time	Method
Radiological examination	14days	Coronal and Sagittal Alignment

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey