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Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA)

24 de setembro de 2019 atualizado por: Carlos Higuera-Rueda, The Cleveland Clinic

To Determine the Economic and Functional Impact of Peri-Operative Extension Assist Pneumatic Bracing for Primary Total Knee Arthroplasty (TKA) Non-Inferiority Trial

While bracing has been shown to be beneficial for patients with osteoarthritis (OA) in terms of function and strength, whether these unloader braces are also similarly beneficial after total knee arthroplasty (TKA) surgery needs to be examined. Therefore the investigators questioned whether wearing a brace that has previously been shown to increase strength and function in OA patients can also increase strength and function in patients after TKA.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

9

Estágio

  • Não aplicável

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
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic

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

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

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Age: 50 years or older

Exclusion Criteria:

  • BMI > 40
  • Radiographic deformity of greater than 10 degrees

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

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Control group
Subjects will receive two out-patient physical therapy (PT) visits per week for 2 weeks, followed by additional PT visits at clinician's discretion after TKA.
Experimental: Bracing group
Subjects will be fitted with the Ongoing Care Solutions, Inc (OCSI) Rehabilitator brace prior to surgery. This brace will be worn for 6 weeks before surgery. The brace will be worn again after surgery ~10 days after surgery or when staples are removed until the end of the study. Participants will also have two PT visits per week for 2 weeks, followed by additional PT visits at clinician's discretion.
Dispositivo: OCSI Rehabilitator brace
Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces. Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Physical Therapy Visits
Prazo: Total number of visits from date of surgery to 12 weeks after surgery
Investigators will monitor the total number of physical therapy visits that was necessary to return to normal function between the control and bracing group and how it relates to overall cost.
Total number of visits from date of surgery to 12 weeks after surgery

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Visual Analog Scale (VAS) for Pain (0-10 Scale)
Prazo: Change from baseline to 12 weeks after surgery
Visual Analog Scale is a a pain scale assessment instrument that has been widely used to allow adult patients to report their pain level in musculoskeletal research studies. It is a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 two ends representing the extremes of measurements with 0 point representing no pain and 10 representing the worst pain a patient may have had. Therefore, starting from zero point, increasing numbers demonstrate worse pain. Patient can pick a point on the scale that they believe represent their pain level at a given moment.
Change from baseline to 12 weeks after surgery
Timed up and go Test (Timed Measurement)
Prazo: Change from baseline to 12 weeks after surgery
Used to assess a person's mobility and balance. It is measured in time units (seconds or minutes) using a stopwatch by a study personnel. To perform, the patient sits back in a standard arm chair and a line 3 meters, or 10 feet away on the floor is identified. At the investigator mark, the stopwatch is started and the patient is asked to stand up from chair, walk to the end of the line and come back to his chair at normal pace. The results is the time in seconds needed for the patient to perform the test (getting up from chair and coming back to it as timed by the investigator's stopwatch)
Change from baseline to 12 weeks after surgery
Timed Stair Climb (Timed Measurement Over Fixed Distance)
Prazo: Change from baseline to 12 weeks after surgery
Used to assess a person's mobility and balance
Change from baseline to 12 weeks after surgery
One-leg Stance Time (Timed Measurement)
Prazo: Change from baseline to 12 weeks after surgery
Used to assess a person's balance. Performed with eyes open and arms on hips. The patient is asked to stand unassisted on one leg and is timed in seconds (using stopwatch) from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips.
Change from baseline to 12 weeks after surgery
6 Minute Walk Test (Distance Measurement)
Prazo: Change from baseline to 12 weeks after surgery
Used to assess a person's endurance and aerobic capacity. The score of the test is distance a patient walks in 6 minutes. Longer distances walked by the patient in 6 minutes correlates with better performance. Distance is measured using distance measuring wheel.
Change from baseline to 12 weeks after surgery
Knee Society Score Questionnaire
Prazo: Change from baseline to 12 weeks after surgery
Clinical outcome questionnaire developed by the consensus of the Knee Society. It comprises, a "Knee score" and a "Functional score." The Knee score assesses pain, stability, and range of motion. A maximum score of 100 is achieved by a painless, well-aligned knee with 125° range of motion, with neither anteroposterior nor mediolateral instability. Deductions are made for flexion contracture, extension lag, and malalignment. The Functional score assesses walking distance and stair climbing. A maximum score of 100 is assigned to individuals who can walk unlimited distances and can climb up and down stairs normally. Deductions are made for use of a walking stick or crutches. Therefore, higher scores correlate with better function and outcome.
Change from baseline to 12 weeks after surgery
Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS Jr.) Questionnaires
Prazo: Change from baseline to 12 weeks after surgery
Clinical outcome questionnaire that measure joint-specific pain and physical function. It has seven questions that focus on three categories: joint pain, stiffness, and function, in daily living. Raw scores are added up (range 0-28) and converted to an interval score (0-100) using an interval table. The interval score represents a patients total joint disability where 0 corresponds to total joint disability and 100 perfect joint health.
Change from baseline to 12 weeks after surgery
Hospital for Special Surgery (HSS) Score (0-100 Scale)
Prazo: Change from baseline to 12 weeks after surgery
Clinical outcome assessment tool. It is based on a total of 100 points. The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions. The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria. The higher the score, the better the outcome. Approximately 50% of the score is based on a patient interview and the remaining on physical exam.
Change from baseline to 12 weeks after surgery
Type of Pain Medication Used
Prazo: Change from baseline to 12 weeks after surgery
Investigators will monitor the medical record for types of pain medications used.
Change from baseline to 12 weeks after surgery
Amount of Pain Medication Used
Prazo: Change from baseline to 12 weeks after surgery
Investigators will monitor the medical record for the amount of pain medication used
Change from baseline to 12 weeks after surgery

Colaboradores e Investigadores

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

Patrocinador

The Cleveland Clinic

Investigadores

  • Cadeira de estudo: Spindler Kurt, MD, Department Chair

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)

5 de outubro de 2017

Conclusão Primária (Real)

1 de janeiro de 2018

Conclusão do estudo (Real)

1 de janeiro de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

10 de julho de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de agosto de 2017

Primeira postagem (Real)

24 de agosto de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de outubro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de setembro de 2019

Última verificação

1 de setembro de 2019

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SHB-OCSI007

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

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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