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

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ClinicalTrials.gov Identifier: NCT04413565
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Orkhan Aliyev, Bezmialem Vakif University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infection Joint Joint Infection Arthroplasty Complications Procedure: Simultaneous bilateral total knee arthroplasty Procedure: Sequenced bilateral TKA Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
Actual Study Start Date : December 8, 2016
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Two surgeon bilateral TKA group
2 surgeons will perform simultaneous total knee arthroplasty in this group.
Procedure: Simultaneous bilateral total knee arthroplasty
Two surgeon bilateral TKA group

Active Comparator: Single surgeon bilateral TKA group
One surgeon will perform sequentially tptal knee arthroplasty in this group
Procedure: Sequenced bilateral TKA
Single surgeon bilateral TKA group




Primary Outcome Measures :
  1. Infection incedence [ Time Frame: 90 days ]
    Early infection rates



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 without severe extra-articular deformities


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413565


Locations
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Turkey
Bezmialem Vakif University Recruiting
Istanbul, Fatih, Turkey, 34000
Contact: Orkhan Aliyev    05059917419    orkhanaliyev@outlook.com.tr   
Sponsors and Collaborators
Bezmialem Vakif University
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Responsible Party: Orkhan Aliyev, MD, Resident Doctor in Orthopaedic Surgery, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04413565    
Other Study ID Numbers: 08.12.2016-71306642-050.01.04
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases