- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04214171
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
Intervention / Treatment
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
Additional Relevant MeSH Terms
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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