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Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery

20 de setembro de 2021 atualizado por: Ryan McMillen, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery: A Prospective Analysis

The primary objective of this study is to determine whether immediate weight-bearing following foot and ankle surgery provides similar or superior results to the traditional non-weight-bearing post-operative course, while reducing the disuse atrophy and length of rehabilitation necessary to recover during the transition to weight-bearing following an extended course of non-weight-bearing. This will be done by way of clinical follow-up, serial radiographs and/or other appropriate imaging modalities, and patient reported outcomes by way of AOFAS and SF-36 surveys.

Visão geral do estudo

Status

Rescindido

Condições

Cirurgia do Pé e Tornozelo

Intervenção / Tratamento

Descrição detalhada

The study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two groups; an immediate weight-bearing group or a non-weight-bearing group. The patients will be randomly placed into the study group and control group if they meet all eligibility criteria.

This study will be conducted at 5 investigative clinic sites; West Penn Hospital, Forbes Regional Hospital, Jefferson Regional Hospital, Bethel Park Surgery Center, and Monroeville Surgery. Recruitment will stop when a minimum of 230 subjects are consented.

The study duration will require 7 visits to the clinic plus a surgery day therefore will require a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative visits to the clinics. The entire follow up period will occur over 2 years.

Tipo de estudo

Intervencional

Inscrição (Real)

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
- Pennsylvania
  - Clairton, Pennsylvania, Estados Unidos, 15025
    - Steel Valley Orthopaedic and Sports Medicine
  - Pittsburgh, Pennsylvania, Estados Unidos, 15224
    - The Foot & Ankle Institute/Western Pennsylvania Hospital

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 89 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Males or females age 18 to 89 years
Undergoing foot and ankle surgery
Must be able to read and understand English and consent for themselves

Exclusion Criteria:

Diagnosed peripheral neuropathy
Diagnosed peripheral vascular disease
Documented infection to the surgical extremity
Previous surgery to the surgical limb
Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union
Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

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)

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Outro: Immediate protected weight-bearing	Outro: Weight Bearing Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery Outros nomes: Suporte de peso precoce
Outro: Traditional non weight bearing Strict non-weight-bearing	Outro: Strict non-weight bearing Strict non weight bearing for 6 weeks following foot & ankle surgery Outros nomes: Non-weight bearing

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Prazo: Both Arms: Screening	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Screening
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Prazo: Both Arms: Post-operative 6-8 weeks	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Post-operative 6-8 weeks
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Prazo: Both Arms: Post-operative 3 month	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Post-operative 3 month
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Prazo: Both Arms: Post-operative 12 month	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Post-operative 12 month
Safety/Tolerability/Quality of Life/Satisfaction:Both Patient & Physician Assessment - American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale Prazo: Both Arms: Post-operative 24 month	American Orthopaedic Foot and Ankle Score (AOFAS) Ankle-Hindfoot Scale as it pertains to the patient's ankle/foot. Pain, Function, Alignment Score 0-100, 100 being most healthy	Both Arms: Post-operative 24 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Prazo: Both Arms: Screening	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Screening
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Prazo: Both Arms: Post-operative 6-8 weeks	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Post-operative 6-8 weeks
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Prazo: Both Arms: Post-operative 3 month	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Post-operative 3 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Prazo: Both Arms: Post-operative 12 month	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Post-operative 12 month
Quality of Life/Satisfaction:Patient Report Outcome - 36 Item Short Form Survey (SF36) RAND Prazo: Both Arms: Post-operative 24 month	36 Item Short Form Survey (SF36) RAND. 8 scaled scores, 0-100, 100 being most healthy	Both Arms: Post-operative 24 month

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Screening	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Screening
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 2-3 weeks	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 2-3 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 6-8 weeks	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 6-8 weeks
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 3 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 3 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 6 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 6 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 12 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 12 month
Secondary Outcome: Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 24 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing osseous healing both clinical and radiographic evaluation.	Both arms: Post-operative 24 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Screening	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Screening
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 2-3 weeks	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 2-3 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 6-8 weeks	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 6-8 weeks
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 3 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 3 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 6 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 6 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 12 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 12 month
Safety/Efficacy/Tolerability - Frequency of complications during the perioperative and post-operative periods Prazo: Both arms: Post-operative 24 month	Frequency of complications during the perioperative and post-operative periods, measured by assessing healing outcomes of soft tissue procedures.	Both arms: Post-operative 24 month

Colaboradores e Investigadores

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

Patrocinador

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Investigadores

Investigador principal: Ryan L. McMillen, DPM, FACFAS, Steel Valley Orthopaedic & Sports Medicine

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)

29 de julho de 2019

Conclusão Primária (Real)

15 de julho de 2021

Conclusão do estudo (Real)

15 de julho de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

22 de maio de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de junho de 2019

Primeira postagem (Real)

25 de junho de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de setembro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de setembro de 2021

Última verificação

1 de setembro de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

2019-124JH

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Principal Investigator and Co-Investigators are part of the Allegheny Health Network and will have complete access to all data for the purpose of publication at study completion. No other outside entities are involved in this research study.

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

Não

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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