Early Weight Bearing After Open Wedge High Tibial Osteotomy (OWHTO), Is it Worth?
8. května 2026 aktualizováno: 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.
Přehled studie
Postavení
Aktivní, ne nábor
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
72
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Asyut Governorate
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Asyut, Asyut Governorate, Egypt, 71111
- Assiut University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ano
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinical outcome
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Radiological outcome
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Studijní židle: Hatem Galal Said, Professor, Professor of orthopaedic and trauma surgery, Assiut University
- Ředitel studie: Mohamed Abdel Radi, Professor, Professor of orthopaedic and trauma surgery, Assiut University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
8. března 2024
Primární dokončení (Aktuální)
8. března 2025
Dokončení studie (Odhadovaný)
8. června 2026
Termíny zápisu do studia
První předloženo
28. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
8. května 2026
První zveřejněno (Aktuální)
13. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
8. května 2026
Naposledy ověřeno
1. května 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- High tibial Osteotomy in Knee
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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