- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04214171
Kinematics and Muscle Strength in Two, Five or 10 Years Afther Total Hip Arthroplasty (Arthroplasty)
4. september 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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São Paulo, Brasilien, 04660000
- João Barboza
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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group 2 years
The group underwent total hip arthroplasty at 2 years
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The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
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group 5 years
The group underwent total hip arthroplasty at 5 years
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The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
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group 10 years
The group underwent total hip arthroplasty at 10 years
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The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
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group control
healthy patients
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The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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kinematic analysis of hip movements for flexion
Tidsramme: evaluated at 10 years after hip arthroplasty
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Analysis of the movements of the hip - range of motion for flexion
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evaluated at 10 years after hip arthroplasty
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kinematic analysis of hip movements for extension
Tidsramme: evaluated at 10 years after hip arthroplasty
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Analysis of the movements of the hip - range of motion for extension
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evaluated at 10 years after hip arthroplasty
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kinematic analysis of hip movements for internal rotation
Tidsramme: evaluated at 10 years after hip arthroplasty
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Analysis of the movements of the hip - range of motion for internal rotation
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evaluated at 10 years after hip arthroplasty
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kinematic analysis of hip movements external rotation
Tidsramme: evaluated at 10 years after hip arthroplasty
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Analysis of the movements of the hip - range of motion for external rotation
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evaluated at 10 years after hip arthroplasty
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Vera Lucia Santos Alves, Dr, Faculdade de Ciências Médicas da Santa Casa de São Paulo
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2017
Primær færdiggørelse (Faktiske)
1. september 2017
Studieafslutning (Faktiske)
1. februar 2019
Datoer for studieregistrering
Først indsendt
3. januar 2018
Først indsendt, der opfyldte QC-kriterier
30. december 2019
Først opslået (Faktiske)
2. januar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Joao B
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