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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Brazil
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
group 2 years
The group underwent total hip arthroplasty at 2 years
Diagnostic test: Gait and muscle strength will be assessed
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
Diagnostic test: Gait and muscle strength will be assessed
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
Diagnostic test: Gait and muscle strength will be assessed
The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
group control
healthy patients
Diagnostic test: Gait and muscle strength will be assessed
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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Dietary Supplements

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