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

Gulhane Training and Research Hospital

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Procedure: total knee arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04968600

2021/15

Details and patient eligibility

About

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.

Full 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).

Enrollment: 86 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Posterior-cruciate-ligament-retaining (CR)

Experimental group

Description:

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

Treatment:

Procedure: total knee arthroplasty

posterior-cruciate-ligament-stabilized (PS)

Experimental group

Description:

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

Treatment:

Procedure: total knee arthroplasty