Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty: a Prospective Study.

February 25, 2019 updated by: Claudio Cazarini Junior, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty

Introduction: Total hip arthroplasty has been increasingly used as a means of treating the various pathologies of this joint. However, this surgical reconstruction initially brings important deficits in subjects submitted, such as: inhibition of muscle strength, limitation of range of motion and functional deficit. Therefore, an immediate physiotherapeutic treatment is necessary in the short and long term, taking into account both biomechanical issues and the quality of life of these individuals.

Objective: To evaluate the clinical evolution of individuals submitted to total hip arthroplasty in the ten year period.

Method: Twenty individuals submitted to unilateral total hip arthroplasty will be evaluated by the medical group of hip surgeries of the Brotherhood of Santa Casa de Misericórdia of São Paulo, during a period of ten years. These individuals will undergo a primary clinical evaluation and after signing the consent form, will be evaluated functionally with the HARRIS HIP SCORE and WHOQOL-bref questionnaires and physically with the analysis of muscular strength through manual dynamometry to measure the strength level of the Muscles involved in the bilateral coxo-femoral joint, such as abductors, adductors, flexors, extensors, internal rotators, external rotators, knee joint, such as extensors and flexors, and ankle, plantar flexors. Finally, they will be referred to the kinematic gait analysis, to identify the functional characteristics of these individuals, through reflexive markers at specific anatomical points, where they will walk for 5 minutes on a treadmill at a speed of 1.5km per hour.

Study Overview

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

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

Study Locations

    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 03156001
        • Claudio Cazarini Júnior

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

56 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with total hip arthroplasty through the postero lateral approach

Description

Inclusion Criteria:

  • The inclusion criteria in the study will be: patients submitted to total hip arthroplasty between 2 years (24 months - 35 months), 5 years (60 months - 71 months) and 10 years (120 months - 131 months), age between 50 and 80 years and sign the terms of free and informed consent

Exclusion Criteria:

  • The exclusion criteria will be: patients with a history of prosthesis dislocations or revision of the arthroplasty, pain in the hip or lower limb region, asymmetry of the lower limbs greater than 2 centimeters, previous surgeries in the lower limbs, limitation of range of motion in the joint (Impossible to perform muscle strength tests), use of antidepressive drugs or analgesics of continuous use, chronic diseases not controlled (Hypertension, rheumatoid arthritis and diabetes) and the presence of neuromuscular pathologies

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Muscle Strenght assesment of the hip muscles
2D Kinematics Analysis of the gait
Two Years Group
Muscle Strenght assesment of the hip muscles
2D Kinematics Analysis of the gait
Five Years Group
Muscle Strenght assesment of the hip muscles
2D Kinematics Analysis of the gait
Ten Years Group
Muscle Strenght assesment of the hip muscles
2D Kinematics Analysis of the gait

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strenght
Time Frame: Performed in a single evaluation
Hand-Held dynamometer (Lafayette)
Performed in a single evaluation

Collaborators and Investigators

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

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.

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 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 4, 2018

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ccazarini

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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