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NCT04367272 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

Official title:
Is Second Knee at Risk During Simultaneous Bilateral Total Knee Arthroplasty.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04367272
Other study ID # 27.04.2020-02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2020
Est. completion date June 30, 2021

Study information
Verified date April 2020
Source Bezmialem Vakif University
Contact Orkhan Aliyev, MD
Phone +905059917419
Email orkhanaliyev@outlook.com.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 163
Est. completion date June 30, 2021
Est. primary completion date May 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 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

- severe cardiac insufficiency and morbid obesity

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• First Arthroplasty
First Knee
• Second Arthroplasty
Second Knee

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bezmialem Vakif University

Outcome
Type Measure Description Time frame Safety issue
Primary Local complications Local operation related complications rate 90 days
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