The Effects of a Stainless Steel Suture MGH Flexor Tendon Repair Coupled With Early Aggressive Range of Motion Rehabilitation: a Randomized Controlled Trial
28 de abril de 2011 atualizado por: University of Manitoba
A Pilot Study of a Randomized Controlled Trial Comparing Stainless Steel Suture Repair Coupled With Aggressive Post-Operative Rehabilitation to Polypropylene Suture Paired With Active Range of Motion Rehabilitation
The investigators are comparing the combination of a stainless steel repair and aggressive early active range of motion rehabilitation protocol for flexor tendon lacerations in the hand with a current, accepted treatment offered at our institution.
Outcomes to be assessed will be time to return to work, joint range of motion in the injured fingers, and any potential complications that may arise (ex: surgical infections or repair rupture).
All proposed treatments included in this study are currently being offered at our institution, but not in a randomized fashion.
Visão geral do estudo
Status
Desconhecido
Descrição detalhada
This study will serve as a pilot-study for a future randomized controlled trial.
Adult patients with zone 2 flexor tendon lacerations of the hand (anatomically from the A1 pulley of the hand to the insertion of the flexor digitorum superficialis) who have presented to the emergency room acutely (within 1 week of injury) at the Health Sciences Center in Winnipeg will be asked for their participation in this study.
Consent will be obtained by a plastic surgery resident either in the emergency room or in the plastic surgency emergency decanting clinic.
The investigators will include twenty-four patients in the study, randomized into one of two treatment groups (groups A and B) by block randomization.
Randomization will be done once patients agree to participate in the study.
All patients will be booked for surgery on the emergency slate.
Each treatment group will be treated by a single surgeon who is an expert at treatment of these injuries.
Group A patients will have their laceration(s) repaired using a modified Becker repair technique using stainless steel suture in the operating room, and then will proceed to undergo an aggressive early active range of motion rehabilitation administered by the hand therapists at HSC. Group B patients will undergo a double-locking loop suture repair using polypropylene.
They will then undergo a less aggressive active range of motion rehabilitation protocol which is currently offered to patients at our center.
Follow-up will occur in plastic surgery outpatient clinic at post-operative weeks 1, 2, 4, 6 and 12. Follow-up with hand therapy will be at the discretion of the therapists.
At each visit with hand therapy, joint range of motion will be assessed at the PIP and DIP joints in the affected fingers.
Final range of motion will be assessed using the Strickland system for evaluating flexor tendon surgery outcomes, and will be done by a blinded hand therapist.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
24
Estágio
- Fase 2
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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Manitoba
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Winnipeg, Manitoba, Canadá, R3A 1R9
- Health Sciences Center
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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 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- adults
- living in Winnipeg, Manitoba
- zone II flexor tendon lacerations in a single finger
- able to consent to and comply with surgery
Exclusion Criteria:
- crush injuries
- vascular injuries requiring re-vascularization
- fractures
- infection
- prior hand injury requiring surgery
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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Stainless steel MGH
Patients in this study arm will have their flexor tendon laceration repaired using stainless steel suture (size 3-0) in an MGH repair technique.
They will then undergo aggressive early active range of motion rehabilitation post-operatively.
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Stainless steel suture material will be used (size 3-0) in an MGH repair technique
Patients undergoing this form of rehabilitation will have their splints discontinued at 4 weeks and ideally will be back at work at normal duties by 6 weeks.
This rehabilitation uses more movement at a faster progression than other early active range of motion protocols.
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Comparador Ativo: Polypropylene DOLL
Patients in this study arm will have their flexor tendon laceration repaired using polypropylene suture (size 3-0) in a double-locking loop repair technique.
They will then undergo aggressive early active range of motion rehabilitation post-operatively.
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Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique
Patients undergoing this form of rehabilitation will have their splints discontinued at 6 weeks and ideally will be back at work at normal duties by 10-12 weeks.
This rehabilitation uses less movement at a slower progression than the early AROM rehabilitation protocol specified in the experimental group
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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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Return to work
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit at the above mentioned time periods, the clinician will ask the patient if they have returned to work (if applicable)
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Post-operative weeks 1, 2, 4, 6 and 12
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Finger joint range of motion (PIP, DIP, MCP)
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic / occupational therapy visit, a blinded assessor will determine the total range of motion of the finger DIP, PIP and MCP joints
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Post-operative weeks 1, 2, 4, 6 and 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Compliance with therapy
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic and occupational therapy visit, an assessor will ask the patient if they have been compliant with therapy
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Post-operative weeks 1, 2, 4, 6 and 12
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Rupture
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each follow-up visit with the clinician or occupational therapist, the presence of a rupture will be assessed for clinically.
Alternatively this will be recorded if the patient presents to the emergency room with a flexor tendon rupture
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Post-operative weeks 1, 2, 4, 6 and 12
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Infection
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit, the patient will be assessed clinically for the presence or absence of an infection.
This will also be noted if the patient presents to the emergency room.
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Post-operative weeks 1, 2, 4, 6 and 12
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Attendance with follow-up clinic and occupational therapy
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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The patient's attendance will be determined at each clinic or occupational therapy visit.
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Post-operative weeks 1, 2, 4, 6 and 12
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Use of oral analgesics
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit, the patient will be asked if they are still using oral analgesics
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Post-operative weeks 1, 2, 4, 6 and 12
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Oral antibiotic usage
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic visit, the patient will be asked if they are using oral antibiotics.
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Post-operative weeks 1, 2, 4, 6 and 12
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Wound dehiscence (breakdown)
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each clinic and occupational therapy visit, the patient will be assessed to determine if a wound dehiscence (breakdown) has occurred.
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Post-operative weeks 1, 2, 4, 6 and 12
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Use of occupational therapy adjunctive treatments
Prazo: Post-operative weeks 1, 2, 4, 6 and 12
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At each occupational therapy visit, it will be recorded that they are either using or not using occupational therapy adjunctive treatments (ex: coban tape, ultrasound or electrical stimulation)
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Post-operative weeks 1, 2, 4, 6 and 12
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 junho de 2011
Conclusão Primária (Antecipado)
1 de junho de 2012
Conclusão do estudo (Antecipado)
1 de junho de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
28 de abril de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de abril de 2011
Primeira postagem (Estimativa)
29 de abril de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
29 de abril de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de abril de 2011
Última verificação
1 de fevereiro de 2011
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B2010:119
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Ensaios clínicos em Stainless steel suture
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Centre for Human Drug Research, NetherlandsFacio TherapeuticsConcluídoDistrofia Muscular FacioescapulohumeralHolanda