Early Weight Bearing After Open Wedge High Tibial Osteotomy (OWHTO), Is it Worth?
8 de maio de 2026 atualizado por: Mohamed Abdel-Tawab, Assiut University
The aim of our study is to evaluate the effect of early weight bearing after OWHTO on pain, function and return to normal lifestyle activity.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
The management of medial compartment osteoarthritis of the knee in middle-aged patients is challenging. High tibial osteotomy (HTO) is a joint-preserving procedure that can relieve symptoms and return patients back to an active lifestyle. However, both total and uni-compartmental knee arthroplasty can provide good pain relief, but there is concern about the durability of the components in this younger population.
High tibial osteotomy (HTO) is a procedure with proven short-, medium- and long-term efficacy for treating isolated medial tibiofemoral knee osteoarthritis in young subjects with varus knee deformity.
Several studies have shown that the HTO lasts on average 10 years. After this, 74% to 96% of patients require total knee arthroplasty (TKA).
HTO can delay or sometime even avoid the need for arthroplasty. Better functional results have been seen in younger patients. HTO can also be performed to treat medial femoral condyle osteonecrosis or as part of the treatment of ligament injuries with varus malalignment.
The goal of high tibial osteotomy in knees with medial compartment OA is to shift the weight bearing axis from the medial compartment into the lateral compartment. This unloads the damaged medial articular cartilage. To achieve this, two main surgical techniques have been utilized, the lateral closing wedge and the medial opening wedge high tibial osteotomy (MOHTO). The lateral closing wedge HTO has the advantage of early bony healing at the osteotomy site.
Tipo de estudo
Intervencional
Inscrição (Real)
72
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
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Asyut Governorate
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Asyut, Asyut Governorate, Egito, 71111
- Assiut university
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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
- Filho
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
Inclusion Criteria:
- Age from 15 to 60 years old.
- Medial compartmental knee OA.
- With or without medial meniscal injury.
- With or without Cartilage defect.
- Genu varus from 5-15 degrees .
- Flexion deformity < 10 degree .
Exclusion Criteria:
- Older than 50 years old and younger than 15 years old.
- Multiligament injury.
- Lateral compartmental knee OA > GII.
- Genu varus < 5 or > 15 degree .
- Flexion deformity > 10 degree .
- Associated ligamentous reconstruction.
- Revision HTO.
- Meniscal root repair.
- Lateral meniscal injury.
- Mal-united Fr. Tibial plateau.
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)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Early weight bearing group
this group underwent High tibial osteotomy and started early partial weight bearing post-operative at week 2 using crutches.
Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation.
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this group underwent High tibial osteotomy and started early partial weight bearing post-operative at week 2 using crutches and restricted 20 kg of load for 4 weeks.
Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation.
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Comparador Ativo: Non weight bearing group
this group underwent High tibial osteotomy and started weight bearing post-operative at week 6.
Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation.
this is a control group
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the group underwent High tibial osteotomy and started weight bearing post-operative at week 6.
Quadriceps strengthening exercises, continues flexion and extension of the knee were added also to this protocol of post-operative rehabilitation.
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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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Clinical outcome
Prazo: All patients of both groups underwent a clinical evaluation at 6-weeks, 3-months and 6-months post-operatively to assess knee range of motion and return to daily activity life.
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We used The nternational Knee Documentation Committee (IKDC) score as a validated, patient-reported outcome measure designed to quantify functional limitations, symptoms, and sports activity levels across a broad range of knee pathologies.
IKDC scores are utilized to objectively assess a patient's ability to perform activities of daily living and to establish data-driven benchmarks for Return-to-Sport (RTS).
Furthermore, by providing a longitudinal perspective on recovery, the scale allows us to monitor the progression of clinical improvement and determine the overall efficacy of surgical and rehabilitative interventions.
The IKDC utilizes a normalized scale ranging from 0 to 100.
A score of 0 represents the lowest possible level of function, indicating severe physical limitations and significant symptomatic distress.
Conversely, a score of 100 represents the highest possible outcome, a total absence of symptoms and no limitations in either strenuous sports activities or daily living.
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All patients of both groups underwent a clinical evaluation at 6-weeks, 3-months and 6-months post-operatively to assess knee range of motion and return to daily activity life.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Radiological outcome
Prazo: Assessment of both groups was performed using weight-bearing standing radiographs to evaluate the degree of varus correction and screen for potential complications at 2-weeks (group1), 6-weeks, 3-months and 6-months postoperative.
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Preoperative radiological evaluation of all patients included conventional radiography. Assessment of group 1 was performed using weight-bearing standing radiographs to evaluate the degree of varus correction and screen for potential complications at 2-weeks, 6-weeks, 3-months and 6-months postoperative. Assessment of group 2 was performed using weight-bearing standing radiographs and long film at 6-weeks, 3-months and 6-months postoperative. |
Assessment of both groups was performed using weight-bearing standing radiographs to evaluate the degree of varus correction and screen for potential complications at 2-weeks (group1), 6-weeks, 3-months and 6-months postoperative.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Cadeira de estudo: Hatem Galal Said, Professor, Professor of orthopaedic and trauma surgery, Assiut University
- Diretor de estudo: Mohamed Abdel Radi, Professor, Professor of orthopaedic and trauma surgery, Assiut University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 1. Dean, C.S., et al., Clinical outcomes of high tibial osteotomy for knee instability: a systematic review. Orthopaedic journal of sports medicine, 2016. 4(3): p. 2325967116633419. 2. Gkekas, N.K., et al., Medial open wedge high tibial osteotomy is a viable option in young patients with advanced arthritis in a long-term follow-up. Knee Surgery, Sports Traumatology, Arthroscopy, 2025. 33(3): p. 1025-1032. 3. Kim, K.J., et al., Biomechanical study of the fixation plates for opening wedge high tibial osteotomy. Knee Surgery & Related Research, 2015. 27(3): p. 181. 4. Van Haeringen, M., et al., Opening-and closing-wedge high tibial osteotomy are comparable and early full weight bearing is safe with angular stable plate fixation: a meta-analysis. Knee Surgery, Sports Traumatology, Arthroscopy, 2023. 31(7): p. 3015-3026. 5. Lansdaal, J.R., et al., Early weight bearing versus delayed weight bearing in medial opening wedge high tibial osteotomy: a randomized controlled trial. Knee Surgery, Sports Traumatology, Arthroscopy, 2017. 25(12): p. 3670-3678. 6. Jiang, Y., et al., Clinical and radiographic outcomes of double-triangle locking compression plate (DT-LCP) versus T-shaped locking compression plate (T-LCP) in medial open-wedge high tibial osteotomy: a follow-up study of over 5 years. Journal of Orthopaedic Surgery and Research, 2026. 21(1): p. 1. 7. Saad, R., et al., Six Weeks in Orthopedics: Biological Basis, Clinical Practice, and Evidence for a Universal Benchmark. Orthopedic Reviews, 2026. 18: p. 156461. 8. Elsenosy, A.M., et al., Early Versus Delayed Weight-Bearing Following Tibial Plateau Fracture Surgery: A Systematic Review and Meta-Analysis. Cureus, 2025. 17(10). 9. Higgins, L.D., et al., Reliability and validity of the International Knee Documentation Committee (IKDC) subjective knee form. Joint Bone Spine, 2007. 74(6): p. 594-599. 10. Collins, N., et al., Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis and cartilage, 2016. 24(8): p. 1317-1329. 11. Resch, T., et al., Open-wedge high tibial osteotomy with and without bone void filler: Allograft leads to faster bone union and weight bearing with comparable return to work and sports rates. Knee Surgery, Sports Traumatology, Arthroscopy, 2024. 32(7): p. 1785-1797. 12. Rocca, M.S., K. Dias, and J.D. Hughes, Joint preservation procedures: osteotomies about the knee. Annals of joint, 2025. 10: p. 17. 13. Azuma, T., et al., In-hospital grouping rehabilitation of hybrid closed-wedge high tibial osteotomy results in shorter hospital stays and better clinical outcomes. Journal of Physical Therapy Science, 2023. 35(8): p. 575-580. 14. Ueda, Y., et al., Knee extensor strength normalised to body weight is associated with patient-reported outcomes at 12 months after open-wedge high tibial osteotomy. Journal of Experimental Orthopaedics, 2026. 13(1): p. e70625. 15. Nha, K.-W., et al., Fixation stability and stress redistribution following metal block use in opening-wedge high tibial osteotomy: a finite element analysis. Frontiers in Bioengineering and Biotechnology, 2025. 13: p. 1703140. 16. Franulic, N., et al., Lateral hinge fracture in medial opening wedge high tibial osteotomy: a narrative review. EFORT Open Reviews, 2023. 8(7): p. 572-580.
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)
8 de março de 2024
Conclusão Primária (Real)
8 de março de 2025
Conclusão do estudo (Estimado)
8 de junho de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
28 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de maio de 2026
Primeira postagem (Real)
13 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- High tibial Osteotomy in Knee
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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Ensaios clínicos em Osteoartrite do joelho
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University of CalgaryHamilton Health Sciences CorporationRecrutamentoPediatria | Lesão musculoesquelética | Entorse e Distensão do Tornozelo | Joelho de entorse | KNIE KNEECanadá