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Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design.

NCT04244838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-09-23

No results posted yet for this study

Summary

The purpose of the present pilot study is to evaluate, through gait analysis and rating scales, the functional outcome during the execution of motor tasks with high functional demand such as walking on an unstable surface, stair ascent and descent, maximal knee flexion under load (lunge) on a sample of 20 subjects candidates to cemented total knee arthroplasty with MP design at the Orthopedic and Traumatology Clinic 2nd of the Rizzoli Orthopedic Institute. The parameters obtained will be compared with the parameters of healthy subjects comparable by age and Body Max Index (BMI) already acquired at the Movement Analysis Laboratory of the Rizzoli Orthopedic Institute, where the study will be conducted.

On the day of admission to the ward (generally the day before the scheduled surgery), the enrolled patients will undergo the evaluation scales and gait analysis at the Institute's Movement Analysis Laboratory.

The patients will be operated by the team of the Traumatological Orthopedic Clinic 2nd through the implantation of a cemented total knee prosthesis MP (Evolution medial-pivot knee system, MicroPort Orthopedics). Anterior knee access with medial para-patellar capsulotomy and standard instruments will be used according to current standards of good clinical practice.

In the post-operative period, patients will carry out post-surgical rehabilitation following normal clinical practice.

The patients will be re-evaluated at a 6-month follow-up through gait analysis and evaluation scales on the occasion of the control visit that takes place, according to the normal clinical practice at the Institute.

Conditions

Interventions

DIAGNOSTIC_TEST

Gait Analysis

The patients will undergo Gait analysis (integrated movement analysis system) performed at the Complex Laboratory for Movement Analysis and functional-clinical evaluation of the prosthesis of the Rizzoli Orthopedic Institute. The instrumentation used in the Movement Analysis Laboratory consists of a stereophotogrammetric system equipped with eight infrared cameras (Vicon® 460-Oxford system) and 2 dynamometric platforms (Kistler® Instrument, AG Switzerland). The IOR GAIT protocol will be used as a marker set (Leardini et al. 2007). For the evaluation of muscle activation, surface electromyography with 16-channel system will be used (ZeroWire Cometa, Milan). Spatio-temporal parameters, kinematics, kinetics and muscle activation will be evaluated.

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Giulio Maria Marcheggiani Muccioli, MD, PhD · IRCCS Istituto Ortopedico Rizzoli

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2024-05-19
Completion
2024-05-19

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04244838 on ClinicalTrials.gov