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Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.

NCT ID: NCT04367272

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-15

Study Completion Date

2021-06-30

Brief Summary

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The effects of single-team simultaneous bilateral total knee arthroplasty on peri- and postoperative complications are clear. The investigators hypothesized that second knee at risk during single-team simultaneous bilateral total knee arthroplasty and have more early postoperative complication rates than the first knee. Therefore, this prospective study compared minor and major local complications for 90 days postoperatively between the first and second during knee single-team simultaneous bilateral total knee arthroplasty.

Detailed Description

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The investigators would like to compare operation related technical complications and periprosthetic joint infection rate between the first and second knee.

Conditions

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Osteoarthritis, Knee Infection Periprosthetic Fracture Around Prosthetic Joint Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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First Knee

The first knee is the knee where the surgery will begin to be applied.

Group Type ACTIVE_COMPARATOR

First Arthroplasty

Intervention Type PROCEDURE

First Knee

Second Knee

The second knee is the knee where the surgeon will apply secondly.

Group Type EXPERIMENTAL

Second Arthroplasty

Intervention Type PROCEDURE

Second Knee

Interventions

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First Arthroplasty

First Knee

Intervention Type PROCEDURE

Second Arthroplasty

Second Knee

Intervention Type PROCEDURE

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
* less than 75 years old
* severe cardiac insufficiency and morbid obesity
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Orkhan Aliyev

Residents Doctor in Orthopedics Department, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Orkhan Aliyev, MD

Role: CONTACT

Phone: +905059917419

Email: [email protected]

Other Identifiers

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27.04.2020-02

Identifier Type: -

Identifier Source: org_study_id