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

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04367272

Collaborator

(none)

163

Enrollment

Arms

13.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis, Knee Infection Periprosthetic Fracture Around Prosthetic Joint Implant	Procedure: First Arthroplasty Procedure: Second Arthroplasty	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

163 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 15, 2020

Anticipated Primary Completion Date :

May 15, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: First Knee The first knee is the knee where the surgery will begin to be applied.	Procedure: First Arthroplasty First Knee
Experimental: Second Knee The second knee is the knee where the surgeon will apply secondly.	Procedure: Second Arthroplasty Second Knee

Arm

Intervention/Treatment

Active Comparator: First Knee

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

Procedure: First Arthroplasty

First Knee

Experimental: Second Knee

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

Procedure: Second Arthroplasty

Second Knee

Outcome Measures

Primary Outcome Measures

Local complications [90 days]
Local operation related complications rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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
severe cardiac insufficiency and morbid obesity

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Orkhan Aliyev, Residents Doctor in Orthopedics Department, Principal Investigator, Bezmialem Vakif University

ClinicalTrials.gov Identifier:

NCT04367272

Other Study ID Numbers:

27.04.2020-02

First Posted:

Apr 29, 2020

Last Update Posted:

Apr 30, 2020

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis, Knee

Periprosthetic Fractures

Study Results

No Results Posted as of Apr 30, 2020