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Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis (Pain+Stiffness)

10 de agosto de 2021 atualizado por: Hospital for Special Surgery, New York
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Real)

179

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos
        • Hospital for Special Surgery

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.

Descrição

Inclusion Criteria:

  • Elective primary unilateral total knee arthroplasty
  • Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
  • Patients of surgeons who have agreed to participate in the study
  • Age > 18 years
  • American Society of Anesthesiologists (ASA) Physical Status 1-3
  • Regional anesthesia
  • Epidural patient-controlled analgesia (PCA) for postoperative pain
  • Adductor canal block for postoperative pain

Exclusion Criteria:

  • Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
  • Use of general anesthesia
  • History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids
  • Preoperative oral steroid use in the past 6 months
  • Intra-articular steroid injection within one month of scheduled surgery in affected joint
  • Non-English speakers
  • Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
  • Peri-articular injections or infusions for postoperative pain
  • Diagnosis of crystalline arthropathy
  • Diagnosis of osteonecrosis
  • Active infection or use of antibiotics
  • Pregnant women

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Total knee arthroplasty patients
Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness.
Procedimento: Total Knee Arthroplasty
Patients will undergo total unilateral knee arthroplasty for osteoarthritis.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Presence of persistent postoperative pain using the numeric rating scale (NRS)
Prazo: 6 months after date of surgery
Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint
6 months after date of surgery

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Incidence of postoperative joint stiffness
Prazo: 6 weeks after date of surgery
Number of patients that experience postoperative joint stiffness, defined as ≤95 degrees range of motion.
6 weeks after date of surgery
Postoperative knee range of motion
Prazo: 6 weeks after date of surgery
Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.
6 weeks after date of surgery
NRS pain at rest on POD1
Prazo: 1 day after surgery
NRS pain at rest on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
1 day after surgery
NRS pain with movement on POD1
Prazo: 1 day after surgery
NRS pain with movement on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
1 day after surgery
Worst NRS pain on POD1
Prazo: 1 day after surgery
Worst NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
1 day after surgery
Least NRS pain on POD1
Prazo: 1 day after surgery
Least NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
1 day after surgery
NRS pain at rest on POD2
Prazo: 2 days after surgery
NRS pain at rest on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
2 days after surgery
NRS pain with movement on POD2
Prazo: 2 days after surgery
NRS pain with movement on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
2 days after surgery
Worst NRS pain on POD2
Prazo: 2 days after surgery
Worst NRS pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
2 days after surgery
Least NRS pain on POD2
Prazo: 2 days after surgery
Least NRS pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
2 days after surgery
NRS pain at rest 4 weeks after surgery
Prazo: 4 weeks after surgery
NRS pain at rest on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
4 weeks after surgery
NRS pain with movement 4 weeks after surgery
Prazo: 4 weeks after surgery
NRS pain with movement on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
4 weeks after surgery
Worst NRS pain 4 weeks after surgery
Prazo: 4 weeks after surgery
Worst NRS pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
4 weeks after surgery
Least NRS pain 4 weeks after surgery
Prazo: 4 weeks after surgery
Least NRS pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
4 weeks after surgery
NRS pain at rest 3 months after surgery
Prazo: 3 months after surgery
NRS pain at rest 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
3 months after surgery
NRS pain with movement 3 months after surgery
Prazo: 6 weeks after date of surgery
NRS pain with movement 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Worst NRS pain 3 months after surgery
Prazo: 6 weeks after date of surgery
Worst NRS pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Least NRS pain 3 months after surgery
Prazo: 6 weeks after date of surgery
Least NRS pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
NRS pain at rest 6 months after surgery
Prazo: 6 weeks after date of surgery
NRS pain at rest 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Least NRS pain 6 months after surgery
Prazo: 6 weeks after date of surgery
Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Worst NRS pain 6 months after surgery
Prazo: 6 weeks after date of surgery
Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
6 weeks after date of surgery
Postoperative knee range of motion
Prazo: 6 weeks after date of surgery
Range of motion (extension minus flexion) at patients postoperative 6 week appointment. Measured by the surgeon or surgical staff. Measured in degrees.
6 weeks after date of surgery
Postoperative KOOS scores
Prazo: 4 weeks, 3 months, and 6 months after date of surgery
4 weeks, 3 months, and 6 months after date of surgery
Postoperative painDETECT scores
Prazo: 4 weeks, 3 months, and 6 months after date of surgery
Neuropathic pain assessment
4 weeks, 3 months, and 6 months after date of surgery
Time to attainment of inpatient physical therapy goals
Prazo: During inpatient hospital stay, approximately 3 days after date of surgery
Goals include ambulation of 40 feet and independent transfer.
During inpatient hospital stay, approximately 3 days after date of surgery
Types of postoperative medications
Prazo: 1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery
Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.
1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hospital for Special Surgery, New York

Investigadores

  • Investigador principal: Meghan Kirksey, MD, PhD, Hospital for Special Surgery, New York

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de dezembro de 2015

Conclusão Primária (Antecipado)

1 de julho de 2022

Conclusão do estudo (Antecipado)

1 de julho de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

8 de dezembro de 2015

Enviado pela primeira vez que atendeu aos critérios de CQ

9 de dezembro de 2015

Primeira postagem (Estimativa)

10 de dezembro de 2015

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de agosto de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de agosto de 2021

Última verificação

1 de agosto de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2015-361

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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