Kinematics and Muscle Strength in Two, Five or 10 Years Afther Total Hip Arthroplasty (Arthroplasty)

September 4, 2020 updated by: Vera Lucia dos Santos Alves, Faculdade de Ciências Médicas da Santa Casa de São Paulo

Kinematics and Muscle Strength in Two, Five or 10 Years Afther Total Hip Arthroplasty: Comparison With Healthy Individuales Controlled Cross Sectional Study

Introduction: Femoral and acetabular replacement is characterized as total hip arthroplasty (THA). It has been used as treatment of various pathologies of this joint. In the postoperative period, some studies have shown that strength, function, range of motion and lower limb mechanics remains altered for more than One year after THA in relation to the non-operated side. However, studies that have correlated kinematics and hip muscle strength in individuals who underwent THA for long time, do not exist in literature. Objective: to evaluate lower limb muscle strength and 2D kinematics during stair ascending and descending in patients undergoing total hip arthroplasty. Methods: Third individuals who underwent total hip arthroplasty (THA) will be recruited at two, five and 10 year postoperative periods. They were allocated in three groups: Group 1 (10n), subjects submitted to THA for two years, Group 2 (10n) subjects submitted to THA for five years, Group 3 (10n) subjects submitted to THA for 10 years and Group 4 (10n) subjects without orthopaedic afections, all will be evaluated for dynamometric isometric muscle strength and kinematic analysis of stair ascending and descending by a "blinded" physical Therapist.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

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, Brazil, 04660000
        • João Barboza

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

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group

Description

Inclusion Criteria:

  • The investigators will recruit 40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group in the periods of two, five and 10 years postoperatively
  • Control group without orthopaedic afections. Inclusion criteria: patients submitted to total hip arthroplasty between two years (24 months - 35 months), five years (60 months - 71 months) and 10 years (120 months - 131 months), aged between 50 and 80 years and sign the terms of free and informed consent

Exclusion Criteria:

  • patients with a history of prosthesis dislocations or revision of arthroplasty
  • hip or lower limb pain
  • asymmetry of the lower limbs greater than two centimeters
  • previous surgeries in the lower limbs
  • limited range of motion in the hip joint
  • use of antidepressive drugs or analgesics for continuous use
  • Presence of neuromuscular pathologies and functional incapacity to perform the activities proposed in the Kinematics analysis.

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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 2 years
The group underwent total hip arthroplasty at 2 years
The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
group 5 years
The group underwent total hip arthroplasty at 5 years
The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
group 10 years
The group underwent total hip arthroplasty at 10 years
The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
group control
healthy patients
The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
kinematic analysis of hip movements for flexion
Time Frame: evaluated at 10 years after hip arthroplasty
Analysis of the movements of the hip - range of motion for flexion
evaluated at 10 years after hip arthroplasty
kinematic analysis of hip movements for extension
Time Frame: evaluated at 10 years after hip arthroplasty
Analysis of the movements of the hip - range of motion for extension
evaluated at 10 years after hip arthroplasty
kinematic analysis of hip movements for internal rotation
Time Frame: evaluated at 10 years after hip arthroplasty
Analysis of the movements of the hip - range of motion for internal rotation
evaluated at 10 years after hip arthroplasty
kinematic analysis of hip movements external rotation
Time Frame: evaluated at 10 years after hip arthroplasty
Analysis of the movements of the hip - range of motion for external rotation
evaluated at 10 years after hip arthroplasty

Collaborators and Investigators

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

Investigators

  • Study Director: Vera Lucia Santos Alves, Dr, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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)

January 1, 2017

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

December 30, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Joao B

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

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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