- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01475604
Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty
Impact of Noninvasive Targeted Pulsed Electromagnetic Field (tPEMF) on Opioid Use, Pain, and Joint Function Following Total Knee Arthroplasty: A Double-Blind, Randomized, Sham-controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Surgeons are continually looking for means to minimize postoperative pain following TKA in order to reduce or eliminate the need for opioid pain medications. Reductions in pain and edema along with improvements in range of motion encourage quicker recovery of joint function and normal activities. Pulsed radio frequency (PRF), a type of electromagnetic field treatment is proven to effectively modulate postoperative pain and edema in plastic surgery. Therefore, PRF has potential as an adjunct therapy for patients recovering from TKA.
The purpose of the current double-blind, randomized, sham-controlled clinical trial is to determine the effectiveness and safety of the Ivivi Torino II, a device that delivers pulsed radio frequency (PRF), a type of electromagnetic field treatment, in patients recovering from TKA for treatment of severe knee OA.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Virginia
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Alexandria, Virginia, Estados Unidos, 22306
- Anderson Orthopaedic Research Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 40 to 80 years
- Primary diagnosis of knee OA
- Appropriate candidate for TKA
- Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
- Consent to the study and willing to comply with study product and methods including follow-up
Exclusion Criteria:
- Body mass index > 40 kg/m2
- Scheduled for bilateral TKA
- Advanced hip, spine, or ankle osteoarthritis that significantly limits ambulation
- Subjects who have any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
- Use of narcotic pain medication for any condition in the last 1 month prior to surgery
- Self-reported diagnosis of post-traumatic or inflammatory arthritis (e.g. rheumatoid or psoriatic)
- Pregnant or lactating female
- Participation in any clinical trial in the past 30 days
- Vulnerable populations including prisoners and nursing home residents
- Any medical condition that, in the opinion of the investigator, may compromise patient safety or confound the assessment of treatment effectiveness
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Falso: Farsa, falso
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Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Outros nomes:
Sham treatment for 4 weeks post-surgery
Outros nomes:
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Comparador Ativo: Targeted pulsed electromagnetic field
|
Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
Outros nomes:
Sham treatment for 4 weeks post-surgery
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
The average daily morphine equivalent dose consumption at 2 weeks post-surgery.
Prazo: 2-week follow-up period from surgery
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2-week follow-up period from surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Post-surgical opioid use during hospitalization and following discharge at 1 and 4 weeks post-surgery.
Prazo: 1 and 4 weeks post-surgery
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1 and 4 weeks post-surgery
|
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Knee pain severity assessed on a 10 cm visual analogue scale (VAS)
Prazo: At intervals over the 4-week follow-up period
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Knee pain will be assessed for "current", pain at the time of data collection and "maximum", maximum pain experience at any point during the day of evaluation
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At intervals over the 4-week follow-up period
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The measurement of knee joint circumference
Prazo: Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
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With patient in supine position, the circumference of the extended knee will be measured 1 cm proximal to the base of the patella using the same type of tape measure in all patients
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Measurement performed preoperatively, on the first or second postoperative day, at the discharge dressing change, and at the 4 week follow-up visit
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Range of motion of the knee joint, assessed using the knee flexion technique
Prazo: Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
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Range of motion will be assessed using the knee flexion technique, which allows the use of a goniometer with the trans-epicondylar axis of the knee joint as the fulcrum.
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Assessed preoperatively, on the first or second postoperative day, at the discharge dressing change (unless discharged within 2 days), and at the 4 week follow-up visit
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OA-related medication use including analgesics, anti-inflammatories, and other non-opioids
Prazo: 4 weeks post-surgery
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Subjects will be required to track daily OA-related medication use including analgesics, anti-inflammatories, and other non-opioids using a daily diary.
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4 weeks post-surgery
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Adverse Events collected and analyzed for confirmation of device safety
Prazo: Randomization to 4 weeks post-surgery
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Subjects will be instructed by the research staff and in the instructions in the daily diary to contact the research staff and/or investigator with any adverse events (AEs).
Adverse events will be recorded daily.
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Randomization to 4 weeks post-surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gerard A. Engh, M.D., Anderson Orthopaedic Research Institute
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IOH-TKA-001
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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