Clinical trial NCT04975165: Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties
Official title: Comparison of Smart-phone Based Gait Analysis Between Simultaneous and Staged Total Knee Arthroplasties
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bilateral Knee Osteoarthritis
Keywords: Bilateral knee arthroplasty
Gait analysis
Smart-phone
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-07-23
Enrollment: 84
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: smart-phone based gait analysis
timeFrame: Change from preoperative gait analysis at 3rd month gait analysis
measure: smart-phone based gait analysis
timeFrame: Change from 3rd month gait analysis at 6th month gait analysis
measure: smart-phone based gait analysis
timeFrame: Change from 6th month gait analysis at 12th month gait analysis
Secondary outcomes:
measure: Knee functional scores
timeFrame: Change from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)
measure: Knee functional scores
timeFrame: Change from 3rd month Knee Society Scores (KSS) at 6th month Knee Society Score (KSS)
measure: Knee functional scores
timeFrame: Change from 6th month Knee Society Scores (KSS) at 12th month Knee Society Score (KSS)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Teaching and Research Hospital
Study officials:
affiliation: Gulhane Teaching and Research Hospital
name: Deniz CANKAYA, Assoc.Prof.
role: STUDY_CHAIR
References: