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

Gonarthrosis; Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04434690
• Other study ID #: 71306642-050.01.04
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: June 2020
• Source: Bezmialem Vakif University
• Contact: Orkhan Aliyev, MD
• Phone: +90 505 991 71 19
• Email: orkhanaliyev[@]outlook.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 31, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gonarthrosis; Primary
• Osteoarthritis, Knee

Intervention

Procedure:
• Simultaneous bilateral total knee arthroplasty
Two surgeons bilateral TKA group
• Sequenced bilateral TKA
Single surgeon bilateral TKA group

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological examination	Coronal and Sagittal Alignment	14days