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Comparison of Gait Pattern Between Simultaneous and Staged Knee Arthroplasties

Comparison of Smart-phone Based Gait Analysis Between Simultaneous and Staged Total Knee Arthroplasties

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04975165
Enrollment
84
Registered
2021-07-23
Start date
2021-05-26
Completion date
2023-01-31
Last updated
2021-07-29

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

Conditions

Bilateral Knee Osteoarthritis

Keywords

Bilateral knee arthroplasty, Gait analysis, Smart-phone

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).

Interventions

PROCEDURETotal knee arthroplasty

Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty

Sponsors

Gulhane Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
smart-phone based gait analysisChange from preoperative gait analysis at 3rd month gait analysisGait analysis (The gait velocity, step time (ST), step length (SL), cadence, step length symmetry and step time symmetry) 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
Backup ContactAnıl Ozgur, MD
dr.anilozgur@gmail.com+90 554 3281193

Outcome results

None listed

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