Mobilização imediata versus 2 semanas de imobilização gessada após fratura do rádio distal tratada com placa de bloqueio volar (LIMPER-DRF)
Mobilização imediata versus 2 semanas de imobilização gessada após fratura do rádio distal tratada com placa de bloqueio volar - um protocolo de estudo para um estudo prospectivo, randomizado e controlado
The aim of this study is to analyze total lenght of the sick leace and functional outcome (PRWE) at 2 months between 2 weeks casting and immediate mobilization following volar plating for a DRF.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study is a prospective, randomized, controlled trial. The aim of this study will be to compare the early postoperative outcomes of the patients enrolled in the early mobilization with those patients in post-operative 2-week casting following volar plating for a DRF. Co-primary outcome in this study will be the total lenght of sick leave and Patient-Rated Wrist Evaluation (PRWE) 2 months after the operation.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Intra- or extra articular DRF (Colles, Smith, Volar barton)
- operative treatment justified
Exclusion Criteria:
- Refusal to participate in the study
- Open fracture with a severity greater than Gustilo grade 1
- Patient aged less than 18 or over 65
- Patient does not understand written or spoken guidance in local languages
- Pathological fracture
- Previous fracture in the same wrist or forearm in the last 10 years, that has led to impairment of function
- Ipsilateral fracture in upper extremity
- Associated fractures of the ulna (except fractures of the PSU)
- Polytrauma
Plano de estudo
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 |
|---|---|
|
Experimental: Mobilização imediata após fratura do rádio distal tratada com placa volar bloqueada
|
Immediate mobilization postoperatively without casting Volar plating of distal radius fracture |
|
Comparador Ativo: 2 semanas de imobilização gessada após fratura do rádio distal tratada com placa volar bloqueada
|
Volar plating of distal radius fracture Dorsal cast placed in OR |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
Prazo: 2 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
2 months
|
|
Total lenght of the sick leave
Prazo: 12 months
|
Total number of days of work during the 1 year study period |
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient-rated wrist evaluation questionnaire
Prazo: 4 weeks
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
4 weeks
|
|
Patient-rated wrist evaluation questionnaire
Prazo: 6 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
6 months
|
|
Patient-rated wrist evaluation questionnaire
Prazo: 12 months
|
The PRWE is a 15-item questionnaire designed to measure wrist pain and disability in daily activities. It ranges from 100 (worst) to 0 (best). It consists of 2 subscales. Pain subscale contains 5 items. Function subscale contains total 10 items which are further divided into 2 sections: specific activities (having 6 items) and usual activities. |
12 months
|
|
Return to work
Prazo: 4 weeks
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
4 weeks
|
|
Return to work
Prazo: 2 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
2 months
|
|
Return to work
Prazo: 6 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
6 months
|
|
Return to work
Prazo: 12 months
|
Patient is asked if he or she has returned to the previous work. If no patient is asked is he or she Still on sick leave, partial sick leave or returned to other work. |
12 months
|
|
Complications
Prazo: 4 weeks
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
4 weeks
|
|
Complications
Prazo: 2 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
2 months
|
|
Complications
Prazo: 6 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
6 months
|
|
Complications
Prazo: 12 months
|
Any surgery related complication: wound dehiscence, deep infection, flexor tendon rupture, nerve injury, mechanical complications, nonunion, malunion, complex regional pain syndrome |
12 months
|
|
Self-perceived working ability
Prazo: 4 weeks
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
4 weeks
|
|
Self-perceived working ability
Prazo: 2 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
2 months
|
|
Self-perceived working ability
Prazo: 6 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
6 months
|
|
Self-perceived working ability
Prazo: 12 months
|
Patient is asked to rate his os her working ability using two scales: NRS from 0 (fully disabled) to 10 (best capability) and ordinally (fully capable, partially capable, fully disabled). |
12 months
|
|
Visual analogue pain scale
Prazo: 4 weeks
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
4 weeks
|
|
Visual analogue pain scale
Prazo: 2 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
2 months
|
|
Visual analogue pain scale
Prazo: 6 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
6 months
|
|
Visual analogue pain scale
Prazo: 12 months
|
Overall pain during last 7 days in a scale from 0 to 100 (worst) |
12 months
|
|
Patient-acceptable symptom state
Prazo: 2 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
2 months
|
|
Patient-acceptable symptom state
Prazo: 6 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
6 months
|
|
Patient-acceptable symptom state
Prazo: 12 months
|
Patient satisfaction will be measured using the patient-acceptable symptom state (PASS).The questionnaires will include the following questions: Would you be willing to take the same treatment again if the treatment result was as it is now? (Yes/No) Considering all the different ways your injury is affecting you, if you would remain in this state, do you feel that your current state is satisfactory (Yes/No)? |
12 months
|
|
Work capacity
Prazo: 4 weeks
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
4 weeks
|
|
Work capacity
Prazo: 2 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
2 months
|
|
Work capacity
Prazo: 6 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
6 months
|
|
Work capacity
Prazo: 12 months
|
The participants will be asked to rate their working capacity on a numerical scale from 0 to 10, with "0" being not able to work at all and "10" being the ability to work at its best. |
12 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient activity
Prazo: 4 weeks
|
Patient activity measured with triaxial wrist accelerometer |
4 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Aleksi Reito, Tampere University Hospital
- Investigador principal: Laura Kärnä, MD, Tampere University Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
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
- R21111
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Data is available on reasonable request.
Prazo de Compartilhamento de IPD
After the study has been completed and for 10 years after.
Critérios de acesso de compartilhamento IPD
On reasonable request and research plan for IPD use should be provided.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
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