Clinical trial NCT04968600: Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Arthroplasties
Official title: Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Total Knee Arthroplasties: Gait Analysis With a Smartphone Application
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: knee arthroplasty
gait analysis
smart-phone
Lead sponsor: Gulhane Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-07-20
Enrollment: 86
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In total knee arthroplasty (TKA), the posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) techniques are widely used depending on the individual preference of the surgeon. Comparative analysis of these two techniques is a major topic of investigation in arthroplasty research. The hypothesis of the present study is that compared with the CR technique, the PS technique is associated with a worse gait pattern. Smart-phone based gait analysis and patient-reported functional outcomes are evaluated in patients undergoing total knee arthroplasty with a CR and a PS technique, at 3, 6, and 12 months postoperatively.

Detailed description: Patients undergoing total knee arthroplasty are randomized to posterior-cruciate ligament-retaining (CR) and posterior-cruciate-ligament stabilized (PS) groups by generating random numbers with Microsoft Excel. The patients are/will be evaluated preoperatively and at 3, 6, and 12 months postoperatively, with knee scores (KSS and KOOS), 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 unilateral 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
* Bilateral 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
affiliation: Gulhane Teaching and Research Hospital
name: Denizhan SIVRI, MD
role: PRINCIPAL_INVESTIGATOR
References: