- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03079479
Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty: a Prospective Study.
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
São Paulo
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Sao Paulo, São Paulo, Brazil, 03156001
- Claudio Cazarini Júnior
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Control Group
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Muscle Strenght assesment of the hip muscles
2D Kinematics Analysis of the gait
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Two Years Group
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Muscle Strenght assesment of the hip muscles
2D Kinematics Analysis of the gait
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Five Years Group
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Muscle Strenght assesment of the hip muscles
2D Kinematics Analysis of the gait
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Ten Years Group
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Muscle Strenght assesment of the hip muscles
2D Kinematics Analysis of the gait
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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)
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Performed in a single evaluation
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Giannotti S, Bottai V, Dell'Osso G, De Paola G, Bugelli G, Guido G. The hip prosthesis in lateral femur fracture: current concepts and surgical technique. Clin Cases Miner Bone Metab. 2014 Sep;11(3):196-200.
- Liu XW, Zi Y, Xiang LB, Wang Y. Total hip arthroplasty: areview of advances, advantages and limitations. Int J Clin Exp Med. 2015 Jan 15;8(1):27-36. eCollection 2015.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ccazarini
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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