Effects of Unloader Bracing in Clinical Outcome and Cartilage Physiology Following Microfracture of Chondral Defects (Mfxbracing)
Effects of Unloader Bracing in Clinical Outcome and Articular Cartilage Physiology Following Microfracture of Isolated Chondral Defects
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The study will examine clinical and radiographic outcomes of microfracture surgery (a common technique to address isolated areas of cartilage loss) in the knee used with or without unloader bracing. Radiographic outcome will be assessed via MRI scans post-operatively. Randomly selected patients will wear an unloader brace, which is designed to take pressure off the area of the knee which underwent repair, for several weeks after surgery. Our hypothesis is that bracing may improve clinical and or radiographic outcomes.
The surgery performed will be the same for all patients
The length of follow up and schedule of post-operative MRI will be the same for all patients.
The only difference in groups will be presence of absence of brace wear.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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Redwood City, California, Estados Unidos, 94063
- Stanford University Medical Center
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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:
- isolated chondral defect of medial or lateral femoral condyle 2cm squared or less
- age 15-40
- neutral knee alignment
Exclusion Criteria:
- prior cartilage procedures performed in the same knee
- other significant knee pathology including meniscus tears, ligament tears or inflammatory arthritis
Plano de estudo
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 |
|---|---|
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Experimental: Unloader Bracing
This group will be randomly selected and assigned to wear an unloader brace post-operatively during the study period.
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The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
Outros nomes:
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Comparador Ativo: Non-Bracing Arm
This group will be randomly selected and assigned to wear no brace post-operatively.
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Microfracture performed with no post-operative unloader bracing
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Knee Injury and Osteoarthritis Outcome Score (KOOS) (Clinical Outcome)
Prazo: 2 years
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KOOS is a validated outcome score that evaluates knee symptoms, knee pain, knee use in activities of daily living, function in sport and recreation and knee-related quality of life.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
Scores between 0 and 100 represent the percentage of total possible score achieved.
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2 years
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Tegner Score (Clinical Outcome)
Prazo: 2 years
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The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports.
The patient is asked to select the level of participation that best describes their current level of activity and that before injury.
A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports.
A score >6 can only be achieved if the person participates in recreational or competitive sport.
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2 years
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Change From Baseline in SF-12 Quality of Life Score (Clinical Outcome)
Prazo: 2 years
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SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey which, when combined, scored and weighted, results in two scales of mental and physical functioning and overall health-related quality of life.
A higher value indicates a better quality of life of the patient.
The scores range from 0 to 100.
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2 years
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Change From Baseline in Lysholm Score (Clinical Outcome)
Prazo: 2 years
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The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.
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2 years
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Change From Baseline in T2 Relaxation Time (Radiographic Outcome)
Prazo: 2 years
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T2 imaging assesses hydration of cartilage as well as collagen fiber orientation and loss of type II collagen.
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2 years
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Change From Baseline in Cartilage Volume (Radiographic Outcome)
Prazo: 2 years
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2 years
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Change From Baseline in Cartilage Thickness (Radiographic Outcome)
Prazo: 2 years
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2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jason Dragoo, MD, Stanford University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
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
- oss-mfx-2013
Plano para dados de participantes individuais (IPD)
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