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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double (Participant, Investigator)

Study Groups

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Posterior-cruciate-ligament-retaining (CR)

Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty

Group Type EXPERIMENTAL

total knee arthroplasty

Intervention Type PROCEDURE

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

posterior-cruciate-ligament-stabilized (PS)

Posterior-cruciate-ligament-retaining (CR) technique of total knee arthroplasty

Group Type EXPERIMENTAL

total knee arthroplasty

Intervention Type PROCEDURE

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

Interventions

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total knee arthroplasty

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No