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- Ensaio Clínico NCT07671729
Quadriceps Tendon vs Peroneus Longus Tendon in ACL Reconstruction
A Prospective Randomized Clinical Trial Comparing Quadriceps Tendon and Peroneus Longus Tendon Autografts in Anterior Cruciate Ligament Reconstruction: Clinical, Functional, and Gait Analysis Outcomes
Visão geral do estudo
Status
Descrição detalhada
Anterior cruciate ligament (ACL) reconstruction is one of the most commonly performed orthopedic procedures for restoring knee stability and enabling return to sports activities after ACL injury. Various autograft options have been described for ACL reconstruction, including hamstring tendon, bone-patellar tendon-bone, quadriceps tendon, and more recently, peroneus longus tendon grafts. Each graft option has unique biomechanical characteristics, advantages, and potential donor site morbidities.
Quadriceps tendon autografts have gained increasing popularity because of their adequate graft diameter, favorable biomechanical properties, and relatively low donor site complications. Peroneus longus tendon autografts have also emerged as a promising alternative graft source with satisfactory clinical outcomes and sufficient graft size. However, concerns remain regarding donor site morbidity, particularly potential effects on ankle muscle strength and ankle function following peroneus longus tendon harvesting.
This prospective randomized study aims to compare quadriceps tendon and peroneus longus tendon autografts in patients undergoing primary ACL reconstruction. Patients will be randomly assigned into two groups according to graft type. Clinical evaluations, functional knee scores, return-to-sport outcomes, ankle muscle strength assessments, ankle-related functional scores, and gait analysis parameters will be assessed during postoperative follow-up.
Follow-up evaluations will be performed at 6 months and 12 months after surgery. The findings of this study are expected to contribute to graft selection strategies in ACL reconstruction by providing comparative data regarding clinical outcomes, functional recovery, gait characteristics, and donor site morbidity.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Besiktas
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Istanbul, Besiktas, Turquia (Türkiye), 34349
- Recrutamento
- Acibadem Fulya Hospital, Sport Medicine Center
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Contato:
- Tunay Erden, M.D.
- Número de telefone: +905546289045
- E-mail: tunayerden@gmail.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients diagnosed with anterior cruciate ligament rupture
- Patients scheduled for primary anterior cruciate ligament reconstruction
- Age between 18 and 50 years
- Ability to provide informed consent
- Willingness to comply with postoperative rehabilitation and follow-up evaluations
Exclusion Criteria:
- Previous ligament reconstruction surgery on the affected knee
- Multi-ligament knee injuries requiring additional ligament reconstruction
- Severe osteoarthritis of the knee
- Revision anterior cruciate ligament reconstruction
- Neuromuscular disorders affecting lower extremity function
- Active infection
- Inability to comply with follow-up protocol
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 |
|---|---|
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Experimental: Quadriceps Tendon Autograft
Patients undergoing anterior cruciate ligament reconstruction using quadriceps tendon autograft.
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Anterior cruciate ligament reconstruction performed using quadriceps tendon autograft.
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Experimental: Peroneus Longus Tendon Autograft
Patients undergoing anterior cruciate ligament reconstruction using peroneus longus tendon autograft.
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Anterior cruciate ligament reconstruction performed using peroneus longus tendon autograft.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Subjective Knee Score
Prazo: 12 months postoperatively
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Comparison of postoperative subjective knee function between quadriceps tendon and peroneus longus tendon autograft groups using the International Knee Documentation Committee (IKDC) subjective knee evaluation form.
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12 months postoperatively
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Return to Sport Rate
Prazo: Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
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6 and 12 months postoperatively
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Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
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Ankle Plantar Flexion Strength
Prazo: 6 and 12 months postoperatively
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Isokinetic ankle plantar flexion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during plantar flexion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Dorsiflexion Strength
Prazo: 6 and 12 months postoperatively
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Isokinetic ankle dorsiflexion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during dorsiflexion will be recorded and compared between study groups.
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6 and 12 months postoperatively
|
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Ankle Inversion Strength
Prazo: 6 and 12 months postoperatively
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Isokinetic ankle inversion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during inversion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Eversion Strength
Prazo: 6 and 12 months postoperatively
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Isokinetic ankle eversion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during eversion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Rotational Strength
Prazo: 6 and 12 months postoperatively
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Isokinetic ankle rotational strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during rotational movements will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ground Reaction Force
Prazo: 6 and 12 months postoperatively
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Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Ground reaction force (N) during standardized standing and functional testing tasks will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Force Asymmetry
Prazo: 6 and 12 months postoperatively
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Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Force asymmetry (%) during standardized standing and functional testing tasks will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Weight Distribution
Prazo: 6 and 12 months postoperatively
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Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Weight distribution (%) during standardized standing and functional testing tasks will be recorded and compared between study groups.
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6 and 12 months postoperatively
|
Colaboradores e Investigadores
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Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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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
- Quadriceps vs PL
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