RBR-7k4yks The Use of a Bi-Component (Carboxy Cellulose-Polysaccharide B) on the Knee Right After Ligament Reconstruction

Date of registration: 07/20/2020 ^(mm/dd/yyyy)
Last approval date : 07/20/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1243-5477

• Public title:

  en

  The Use of a Bi-Component (Carboxy Cellulose-Polysaccharide B) on the Knee Right After Ligament Reconstruction

  pt-br

  O Uso de um Bi-Componente (Carboximelcelulose-polissacarideo B) no Joelho logo após Reconstrução Ligamentar do Joelho

• Scientific acronym:

  en

  POL-CARB

  pt-br

  POL-CARB

• Public acronym:

  en

  POL-CARB

  pt-br

  POL-CARB

• Secondaries identifiers:
  • 16312519.1.0000.5505
    Issuing authority: Plataforma Brasil
  • 3.965.186
    Issuing authority: CEP/Unifesp

Sponsors

• Primary sponsor: Unifesp/EPM
• Secondary sponsor:
  • Institution: Unifesp/EPM
• Supporting source:
  • Institution: Unifesp/EPM

Health conditions

• Health conditions:

  en

  Sprain and distention involving the cruciate ligament (anterior)

  pt-br

  Entorse e distensão envolvendo ligamento cruzado (anterior)

• General descriptors for health conditions:

  en

  M00-M99 XIII - Diseases of the musculoskeletal system and connective tissue

  pt-br

  M00-M99 XIII - Doenças do sistema osteomuscular e do tecido conjuntivo

• Specific descriptors:

Interventions

• Interventions:

  en

  Two groups will be compared, 15 patients without intervention and 15 patients with medication intra-articular carboxymethylcellulose-polysaccharide B after anterior cruciate ligament reconstruction (Will be performed at the end of the surgery). -In the first (control), only the saline aspiration will be performed at the end of the surgery. ACL reconstruction. - In the second (intervention), the intraarticular bi-component will be applied at the end of the reconstruction surgery. of the ACL

  pt-br

  Serão comparados dois grupos, 15 paciente sem intervenção e 15 paciente com a medicação carboximetilcelulose-polissacarídeo B intra-articular após a reconstrução do ligamento cruzado anterior (Será realizado ao término da cirurgia). -No primeiro(controle), apenas será realizado a aspiração do soro fisiológico ao final da cirurgia de reconstrução do LCA. - No segundo (intervenção), será aplicado o bi-componente intraarticular ao final da cirurgia de reconstrução do LCA.

• Descriptors:

  en

  E04.555.110.026 Anterior Cruciate Ligament Reconstruction

  pt-br

  E04.555.110.026 Reconstrução do Ligamento Cruzado Anterior

  es

  E04.555.110.026 Reconstrucción del Ligamento Cruzado Anterior

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 11/20/2019 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  30	-	18 Y	45 -

• Inclusion criteria:

  en

  Patients between 18 and 45 years old; isolated anterior cruciate ligament injury

  pt-br

  Pacientes entre 18 e 45 anos; lesão isolada do ligamento cruzado anterior

• Exclusion criteria:

  en

  Patients with active infectious processes; autoimmune or systemic diseases; previous surgery on the injured knee

  pt-br

  Pacientes com processos infecciosos ativos; doenças autoimunes ou sistêmicas; cirurgia pregressa no joelho lesionado

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Single-group	1	Open	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  Assess the patient's pain using the visual analogue pain scale method on the first, third, fifth and seventh postoperative day

  pt-br

  Avaliar a dor do paciente utilizando o método da escala visual analógica de dor no primeiro, terceiro, quinto e sétimo dia pós operatório

  en

  Assess hemarthrosis on the first and seventh postoperative days using a scale from 0 to 4, with 0 - without edema, 1 - presence of fluids 2 - slight lifting of the patella 3 - balloon-shaped patella or tense effusion 4- inability to compress the patella against the femoral groove

  pt-br

  Avaliar a hemartrose no primeiro e sétimo dia pós operatório utilizando-se uma escala de 0 a 4, sendo que 0 - sem edema, 1 - presença de fluidos 2 - ligeiro levantamento da patela 3 - patela em forma de balão ou efusão tensa 4- impossibilidade de comprimira a patela contra o sulco femoral

• Secondary outcomes:

  en

  Evaluate the range of motion of the knee on the first and seventh postoperative day using a goniometer

  pt-br

  Avaliar a amplitude de movimento do joelho no primeiro e sétimo dia pós operatório utilizando -se um goniômetro

Contacts

• Public contact
  • Full name: Renan Moukbel Chaim
  • • Address: Rua João Moura
    • City: São Paulo / Brazil
    • Zip code: 05412-002
  • Phone: 55-11-986254999
  • Email: renanmchaim@yahoo.com.br
  • Affiliation: Unifesp/EPM
  • Full name: Renan Moukbel Chaim
  • • Address: Rua João Moura
    • City: São Paulo / Brazil
    • Zip code: 05412-002
  • Phone: +55-11-986254999
  • Email: renanmchaim@yahoo.com.br
  • Affiliation: Unifesp/EPM
   
• Scientific contact
  • Full name: Renan Moukbel Chaim
  • • Address: Rua João Moura
    • City: São Paulo / Brazil
    • Zip code: 05412-002
  • Phone: 55-11-986254999
  • Email: renanmchaim@yahoo.com.br
  • Affiliation: Unifesp/EPM
  • Full name: Renan Moukbel Chaim
  • • Address: Rua João Moura
    • City: São Paulo / Brazil
    • Zip code: 05412-002
  • Phone: +55-11-986254999
  • Email: renanmchaim@yahoo.com.br
  • Affiliation: Unifesp/EPM
   
• Site contact
  • Full name: Renan Moukbel Chaim
  • • Address: Rua João Moura
    • City: São Paulo / Brazil
    • Zip code: 05412-002
  • Phone: +55-11-986254999
  • Email: renanmchaim@yahoo.com.br
  • Affiliation: Unifesp/EPM
  • Full name: RENAN MOUKBEL CHAIM
  • • Address: Rua Sena Madureira, 1.500.
    • City: SAO PAULO / Brazil
    • Zip code: 04021-001
  • Phone: (11) 3385-4102
  • Email: RENANMCHAIM@YAHOO.COM.BR
  • Affiliation: Unifesp/EPM
   

Additional links:

• Download in ICTRP format