此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Early Weight Bearing After Open Wedge High Tibial Osteotomy (OWHTO), Is it Worth?

2026年5月8日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

72

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Asyut Governorate
      • Asyut、Asyut Governorate、埃及、71111
        • Assiut University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
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.
有源比较器: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
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Clinical outcome
大体时间: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.
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.
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.

次要结果测量

结果测量
措施说明
大体时间
Radiological outcome
大体时间: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.

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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Hatem Galal Said, Professor、Professor of orthopaedic and trauma surgery, Assiut University
  • 研究主任:Mohamed Abdel Radi, Professor、Professor of orthopaedic and trauma surgery, Assiut University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

  • 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.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年3月8日

初级完成 (实际的)

2025年3月8日

研究完成 (估计的)

2026年6月8日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月8日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅