Public trial
RBR-9x99fg8 Assessment of the degree of muscle injury and impairment of strength and movement in Knee Replacement Surgery using a pn...
Date of registration: 02/11/2022 (mm/dd/yyyy)Last approval date : 02/11/2022 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Assessment of the degree of muscle injury and impairment of quadriceps motor function with the use of an optimized tourniquet in Total Knee Arthroplasty
pt-br
Avaliação do grau de lesão muscular e comprometimento da função motora do quadriceps com o uso do torniquete otimizado na Artroplastia Total de Joelho
es
Assessment of the degree of muscle injury and impairment of quadriceps motor function with the use of an optimized tourniquet in Total Knee Arthroplasty
Trial identification
- UTN code: U1111-1266-0962
-
Public title:
en
Assessment of the degree of muscle injury and impairment of strength and movement in Knee Replacement Surgery using a pneumatic tourniquet in an optimized way
pt-br
Avaliação do grau de lesão muscular e comprometimento da força e movimento na cirurgia de colocação de Prótese de Joelho utilizando um garrote pneumático de modo otimizado
-
Scientific acronym:
-
Public acronym:
-
Secondaries identifiers:
-
21118119.4.0000.5273
Issuing authority: Órgão emissor: Plataforma Brasil
-
3.662.887
Issuing authority: Órgão emissor: Comitê de Ética em Pesquisa do Instituto Nacional de Traumato-ortopedia
-
21118119.4.0000.5273
Sponsors
- Primary sponsor: Instituto Nacional de Traumatologia e Ortopedia INTO
-
Secondary sponsor:
- Institution: Instituto Nacional de Traumatologia e Ortopedia INTO
-
Supporting source:
- Institution: Instituto Nacional de Traumatologia e Ortopedia INTO
Health conditions
-
Health conditions:
en
Knee osteoarthritis;
pt-br
Osteoartrite de joelho;
-
General descriptors for health conditions:
en
M25.5 joint pain;
pt-br
M25.5 dor articular;
-
Specific descriptors:
en
M17.1 Knee osteoarthritis;
pt-br
M17.1 Osteoartrite de joelho;
Interventions
-
Interventions:
en
Total knee arthroplasty with optimized tourniquet and without tourniquet. Two groups with 30 patients each will be evaluated. All patients will be evaluated about knee strength in our biokinetics laboratory
pt-br
Artroplastia total de Joelho com torniquete otimizado e sem torniquete. Serão avaliados 2 grupos com 30 pacientes em cada. Todos os pacientes serão avaliados quanto à força no joelho em nosso laboratório de biocinética
-
Descriptors:
en
M17.1 Arthroplasty;
pt-br
M17.1 Artroplastia;
Recruitment
- Study status: Data analysis completed
-
Countries
- Brazil
- Date first enrollment: 08/01/2020 (mm/dd/yyyy)
-
Target sample size: Gender: Minimum age: Maximum age: 60 - 0 0 -
Inclusion criteria:
en
The study will include patients with knee osteoarthritis glued to the cemented TKA and who agreed to participate in the research by signing the Informed Consent Form (ICF).
pt-br
Serão incluídos no estudo pacientes com osteoartrite de joelho submetidos à ATJ cimentada e que concordaram em participar da pesquisa assinando o Termo de Consentimento Livre e Esclarecido (TCLE).
-
Exclusion criteria:
en
Patients with uncontrolled sitemic arterial hypertension and chronic heart disease, smokers, patients with a history of previous surgery on the same joint, patients with evidence of joint infection, patients with congenital or acquired coagulopathies, patients on chronic use of oral and anticoagulants will be excluded from the study. corticosteroids, patients with malignant neoplasms and autoimmune diseases, patients with indication for revision surgery and patients with severe axis deviation of the lower limbs (varus> 10 ° and varus> 15 °).
pt-br
Serão excluídos do estudo pacientes com hipertensão arterial sitsêmica não controlada e cardiopatia crônica, tabagistas, pacientes com histórico de cirurgia prévia na mesma articulação, pacientes com evidências de infecção articular, pacientes com coagulopatias congênitas ou adquiridas, pacientes em uso crônico de anticoagulantes orais e de corticoides, pacientes com neoplasias malignas e de doenças auto-imunes, pacientes com indicação de cirurgia de revisão e pacientes com desvio de eixo grave dos membros inferiores (varo >10° e varo >15°).
Study type
-
Study design:
-
Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Treatment Parallel 2 Double-blind Randomized-controlled N/A
Outcomes
-
Primary outcomes:
en
There were no differences in muscle strength pattern through objective analysis with isokinetic dynamometer over time between groups
pt-br
Não haver diferenças no padrão de força muscular através de analise objetiva com dinamômetro isocinético ao longo do tempo entre os grupos
-
Secondary outcomes:
en
No functional differences through functional score analysis over time between groups
pt-br
Sem diferenças funcionais por meio da análise do escore funcional ao longo do tempo entre os grupos
Contacts
-
Public contact
- Full name: Douglas Mello Pavão
-
- Address: Av Brasil
- City: Rio de Janeiro / Brazil
- Zip code: 20940070
- Phone: 5524992764872
- Email: drdouglaspavao@gmail.com
- Affiliation: Instituto Nacional de Traumatologia e Ortopedia INTO
-
Scientific contact
- Full name: Douglas Mello Pavão
-
- Address: Av Brasil 500 Cajú
- City: Rio de Janeiro / Brazil
- Zip code: 20940-070
- Phone: 5524992764872
- Email: drdouglaspavao@gmail.com
- Affiliation: Instituto Nacional de Traumatologia e Ortopedia INTO
-
Site contact
- Full name: Douglas Mello Pavão
-
- Address: 16 de março 51
- City: Petrópolis / Brazil
- Zip code: 25730000
- Phone: 5524992764872
- Email: drdouglaspavao@gmail.com
- Affiliation: Instituto Nacional de Traumatologia e Ortopedia INTO
Additional links:
Total de Ensaios Clínicos 16962.
Existem 8357 ensaios clínicos registrados.
Existem 4701 ensaios clínicos recrutando.
Existem 241 ensaios clínicos em análise.
Existem 5772 ensaios clínicos em rascunho.