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Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Arthroplasties

Gait Pattern Comparison of Cruciate-retaining and Posterior-stabilized Total Knee Arthroplasties: Gait Analysis With a Smartphone Application

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04968600
Enrollment
86
Registered
2021-07-20
Start date
2021-04-28
Completion date
2023-01-31
Last updated
2021-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

knee arthroplasty, gait analysis, smart-phone

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).

Interventions

PROCEDUREtotal knee arthroplasty

Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty

Sponsors

Gulhane Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Double (Participant, Investigator)

Eligibility

Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
smart-phone based gait analysisChange from preoperative gait analysis at 3rd month gait analysisGait analysis is made using the Gait Analyzer version 0.9.95.0 (Control One LLC, NM, USA) smartphone application

Secondary

MeasureTime frameDescription
Knee functional scoresChange from preoperative Knee Society Scores (KSS) at 3rd month Knee Society Score (KSS)Knee Society Score (KSS) (has two different subscale : Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor )

Countries

Turkey (Türkiye)

Contacts

Primary ContactDeniz CANKAYA, Assoc.Prof.
cankayadeniz78@gmail.com+90 542 6688056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026