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Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

G

Gulhane Training and Research Hospital

Status

Unknown

Conditions

Bilateral Knee Osteoarthritis

Treatments

Procedure: Total knee arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT04975165
2021/16

Details and patient eligibility

About

Total knee arthroplasty is a well-known treatment of the end-stage osteoarthritis of the knee. In the case of bilateral end-stage knee osteoarthritis, both of the knees need total knee arthroplasty. Bilateral total knee arthroplasty could be performed simultaneously or staged according to the preference of the patients. Simultaneous total knee arthroplasty is defined as the replacement of both knees in a single surgery. The major advantage of simultaneous total knee arthroplasty this surgery is that it requires only one hospital stay and a rehabilitation period to recover both knees, but higher blood transfusion rates and thromboembolism risk are still major concerns. Therefore, in this comparative study, smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing simultaneous and staged total knee arthroplasty, at 3, 6, and 12 months postoperatively

Full description

Patients with bilateral end-stage knee osteoarthritis will be included in the current study. Bilateral total knee arthroplasty will be performed simultaneously or staged according to the preference of the patients. We will have two groups: staged total knee arthroplasty and simultaneous total knee arthroplasty groups. The patients will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (Knee Society Scores and Knee Injury and Osteoarthritis Outcome Score), life quality (SF-12), and smart-phone based gait analysis. All data will be calculated as mean and standard deviation values. The Student's t-test will be used for statistical analysis of the patient data. Statistical calculations will be performed using SPSS vn.22.0 software (IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY, USA).

Enrollment

84 estimated patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of bilateral primary knee osteoarthritis Age 55 to 85 years Must be able to walk without support

Exclusion criteria

Rheumatological joint diseases Previous knee surgery Neuromuscular diseases Unilateral knee osteoarthritis Insufficiency of knee collateral ligaments.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Staged total knee arthroplasty
Experimental group
Description:
Staged replacement of both knees in two separate surgeries.
Treatment:
Procedure: Total knee arthroplasty
Simultaneous total knee arthroplasty
Experimental group
Description:
Simultaneous replacement of both knees in a single surgery.
Treatment:
Procedure: Total knee arthroplasty

Trial contacts and locations

1

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Central trial contact

Anıl Ozgur, MD; Deniz Cankaya, Assoc.Prof.

Data sourced from clinicaltrials.gov

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