Range of Motion and Patients With Distal Radius Fractures
6 de abril de 2011 atualizado por: Mayo Clinic
The Effect of Early vs. Delayed Range of Motion in the Outcome of Patients With Distal Radius Fractures
Hypothesis : Early active range of motion protocol after open reduction and internal fixation of a distal radius fracture with a volar fixed angle locking plate results in earlier return of functional motion, earlier return to work and improved functional outcomes compared delayed mobilization.
Specific Aim:
To compare early range of motion versus delayed motion protocol in distal radius fractures treated with open reduction and internal fixation with a volar fixed angle locking plate with respect to time to fracture union, range of motion, functional outcome measures, return to work and complications.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
You are scheduled for surgery of your broken wrist.
Treatment of broken bones of the wrist, such as distal radius fractures, may require different types of treatment.
For this study this type of fracture will be treated by surgery to place a plate with screws to the broken bone and then a plaster splint will be applied.
After surgery, physical therapy will be started.
Following surgery you will be assigned to one of four groups by the type of wrist fracture (broken bone) you have.
Each person will by chance (the flip of a coin) be put in either the Early or Delayed Range of Motion groups.
Those in the Early Range of Motion groups will begin exercises for motion starting 7 days after surgery.
Those in the Delayed Range of Motion, will begin exercises for motion starting about five weeks after surgery.
Once you begin the exercises to help you get back normal use of your wrist, you will have measurements of how much motion and strength you have in the wrist and hand that was fractured.
The measurements will take about five minutes to complete.
All participants will have an x-ray of the wrist at 2, & 6 weeks following surgery and if needed at other appointments.
At each appointment you will be asked to fill out four questionnaires, asking about pain and how you are getting along with the broken bone in your wrist.
The questionnaires will take about 20 minutes of your time to complete.
At Week 26 you will be asked to record the amount of motion you have in both of your wrists on paper drawings as well as the measurements that we will make.
Working with the drawings will take approximately five minutes.
At Week 52 you will be asked two questions about how satisfied you are with the results of your surgery.
Surgery, x-ray of your wrist, and exercise to help you get back motion of your broken wrist are all standard orthopedic practice for treating a broken wrist bone.
Tipo de estudo
Intervencional
Inscrição (Real)
39
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
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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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 a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
The following criteria must be met to be enrolled:
- Have a closed unstable distal radius fracture
- Have a fracture classified as an AO Type A or C fracture, with or without an ulnar styloid fracture
- Be a male or non-pregnant female at least 18 years of age.
- Understand the requirements of the study and able to provide a written informed consent and comply with the study protocol
- Have the ability to understand and provide written authorization for use and disclosure of personal health information
Exclusion Criteria:
Participants are excluded if they:
Have any of the following conditions
- Concomitant contralateral or ipsilateral upper extremity fractures
- Ipsilateral ulna (excluding styloid) fracture
- Open, multi-fragmentary fracture
- Artery or Nerve injury secondary to fracture
- Have had a previous ipsilateral distal radius fracture in the 2 years prior to enrollment
- Are currently on chemotherapy or radiation therapy
- A history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis
- A history of uncontrolled diabetes
- Are unable to provide consent for the study
- Are unable to make the follow-up appointments required of the study
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: Early
Participants randomized to this arm will begin physical therapy of their fractured wrist approximately one week following surgery
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Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
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Outro: Delayed
Participants randomized to this group will begin physical therapy of their fractured wrist approximately 6 weeks from their surgery.
This is the approximate time frame in which therapy begins for patients not involved in the study.
The term Delayed refers to therapy being delayed in starting from those in the study who begin therapy at one week post-operatively, not a delay in current care practice.
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Physical therapy to instruct participant with exercises to assist in return to normal activities following the healing of their wrist fracture
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Range of motion measurements
Prazo: at each study visit
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at each study visit
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Pinch strength
Prazo: at each study visit
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at each study visit
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Grip strength
Prazo: at each study visit
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at each study visit
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Pain
Prazo: at each study visit
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at each study visit
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Return to work
Prazo: at each study visit
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at each study visit
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Scores of DASH & PRWE questionnaires
Prazo: at each study visit
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at each study visit
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alexander Y. Shin, M.D., Mayo Clinic
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
1 de outubro de 2006
Conclusão Primária (Real)
1 de fevereiro de 2010
Conclusão do estudo (Real)
1 de fevereiro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
5 de janeiro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de janeiro de 2009
Primeira postagem (Estimativa)
6 de janeiro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
8 de abril de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de abril de 2011
Última verificação
1 de abril de 2011
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 06-004364
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 .