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

Primary Purpose

Gonarthrosis; Primary

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Simultaneous bilateral total knee arthroplasty

Sequenced bilateral TKA

About this trial

This is an interventional treatment trial for Gonarthrosis; Primary

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Bezmialem Vakif UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simultaneous

Single surgeon bilateral TKA group

Arm Description

2 surgeons will perform simultaneous total knee arthroplasty in this group.

One surgeon will perform sequentially tptal knee arthroplasty in this group

Outcomes

Primary Outcome Measures

Radiological examination

Coronal and Sagittal Alignment

Secondary Outcome Measures

Full Information

NCT ID

NCT04434690

First Posted

June 13, 2020

Last Updated

June 13, 2020

Sponsor

Bezmialem Vakif University

1. Study Identification

Unique Protocol Identification Number

NCT04434690

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2020 (Actual)

Primary Completion Date

October 30, 2020 (Anticipated)

Study Completion Date

October 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gonarthrosis; Primary

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Simultaneous

Arm Type

Experimental

Arm Description

2 surgeons will perform simultaneous total knee arthroplasty in this group.

Arm Title

Single surgeon bilateral TKA group

Arm Type

Active Comparator

Arm Description

One surgeon will perform sequentially tptal knee arthroplasty in this group

Intervention Type

Procedure

Intervention Name(s)

Simultaneous bilateral total knee arthroplasty

Intervention Description

Two surgeons bilateral TKA group

Intervention Type

Procedure

Intervention Name(s)

Sequenced bilateral TKA

Intervention Description

Single surgeon bilateral TKA group

Primary Outcome Measure Information:

Title

Radiological examination

Description

Coronal and Sagittal Alignment

Time Frame

14days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Orkhan Aliyev, MD

Phone

+90 505 991 71 19

orkhanaliyev@outlook.com.tr

Facility Information:

Facility Name

Bezmialem Vakif University

City

Istanbul

State/Province

Fatih

ZIP/Postal Code

34000

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Orkhan Aliyev

Phone

05059917419

orkhanaliyev@outlook.com.tr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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