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

May 29, 2023 updated by: Istituto Ortopedico Rizzoli

Biomechanical Functional Evaluation Through Gait Analysis in Patients Underwent Total Knee Arthroplasty With a Medial Pivot Design: Pilot Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Total knee prosthesis (PTG) is a widespread surgical procedure that aims to treat severe knee osteoarthritis. This type of intervention has proved successful in reducing chronic pain caused by osteoarthritis and in improving the motor performance of the operated subject as well as the quality of life even if the functional outcome after this procedure is still limited, especially in the execution of more complex and demanding motor tasks (e.g. climbing and descending stairs, walking on unstable surfaces, maximum knee flexion under load) due to the difficulty in finding a prosthetic design that mimics the natural joint biomechanics of a non-arthrosic knee.

Medial Pivot (MP) knee prostheses have been designed to meet these requirements by replicating the morphology of the healthy knee, characterized by a medial compartment with a stable conformation and a movable lateral compartment that moves by rotating around the pivot point. Despite the theoretical premises of this prosthetic model, in literature very few studies have investigated how the MP design translates into an improvement of the functional outcome of the subject operated during the journey, while no study has ever been conducted to evaluate the functional outcome during the execution of more demanding motor tasks although the subjects who undergo knee arthroplasty are always younger and more and more active, with increasingly higher functional needs. To date, gait analysis, a non-invasive functional assessment method that provides objective and quantitative data about spatio-temporal parameters, kinematics, kinetics and muscle activation, represents the Gold Standard for the assessment of functional outcome both in healthy patients and in patients subjected to prosthetic surgery.

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.

The pilot study is necessary to carry out a preliminary assessment of the functional outcome and joint biomechanics of the knee prosthesis with the gait analysis method never performed in other studies during the execution of demanding motor tasks, with high functional demand. The collection of information and data obtained will allow the appropriate calculation of the sample useful for a subsequent study.

During the pre-hospitalization visit, participation in the study will be proposed to those who meet the inclusion criteria. If the subject accepts, he will be recruited and will have to sign the informed consent to the study.

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • IRCCS Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 50-75 years of both gender
  • Patients with three-compartment knee arthrosis (primary or secondary post-traumatic)
  • Patients with femoral or tibial osteonecrosis
  • Patients with posterior cruciate ligament and healthy collateral ligaments at the level of the affected knee
  • Deformity in varus or valgus inferior to 10 °
  • Person able to provide informed consent and who agrees to sign the Informed Consent Form approved by the Ethics Committee (EC).
  • Subject compliant with post-operative rehabilitation to be performed according to normal clinical practice

Exclusion Criteria:

  • Patients with severe morphostructural alterations or other pathologies affecting the knee and lower limb
  • Patients with serious systemic vascular and neurological pathologies
  • Obese or body mass index BMI> 30 kg / m2
  • Patients with posterior cruciate ligament and / or collateral ligaments injury in the affected knee
  • Knee arthroplasty in the contralateral
  • Patient not compliant with post-operative rehabilitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MP-TKA group
20 patients candidates for cemented TKA with MP design for tri-compartment gonarthrosis will be recruited on indications of the surgeon and according to normal clinical practice at the Orthopedic and Traumatological Clinic 2nd of the Rizzoli Orthopedic Institute.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait analysis
Time Frame: 20 months
Spatio-temporal parameters, kinematics of pelvis, hip, knee and ankle in the sagittal coronal and transverse planes, kinetics (joint moments and foot-soil reaction forces), rectus femoral muscle activation, biceps femoris, anterior tibialis, medial twin during the path, ascent and descent from stairs, lunge, path on unstable surface
20 months
American Knee Society Score
Time Frame: 22 months
It is used to assess knee functionality by investigator. It consists of both a clinical and a functional score
22 months
Knee injury and Osteoarthritis Outcome Score
Time Frame: 22 months

KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis.

It consists of five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QoL).
22 months
Visual analogue scale
Time Frame: 22 months
It is used for subjective pain evaluation
22 months
Short Form-36
Time Frame: 22 months
36 items presented in eight dimensions (physical activity, monitoring of the role due to physical health, emotional state, physical pain, perception of the general state of health, vitality, social activities and mental health).
22 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Investigators

  • Principal Investigator: Giulio Maria Marcheggiani Muccioli, MD, PhD, IRCCS Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2019

Primary Completion (Estimated)

July 29, 2024

Study Completion (Estimated)

July 29, 2024

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-TKA-GAIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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