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临床试验/NCT06135454
NCT06135454尚未招募不适用

Open Wedge High Tibial Osteotomy Versus Double Level Osteotomy

Assiut University0 个研究点目标入组 44 人开始时间: 2024年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
主要终点
Occurrence of joint line obliquity (JLO) in the two groups.

研究概览

简要总结

To compare the radiographic and clinical outcomes of varus osteoarthritic knees treated with an open-wedge high tibial osteotomy (OWHTO) alone or with a double-level osteotomy (DLO). It was hypothesized that treatment with DLO would prevent the joint line obliquity (JLO) , optimize post-operative limb alignment and provide better clinical and radiological outcomes after surgery than medial opening-wedge high tibial osteotomy (OWHTO) alone for patients with medial compartment osteoarthritis.

详细描述

Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, hypertrophy of the bone at the margins and subchondral sclerosis(1). Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to be varus deformity of the knee(2). High tibial osteotomy (HTO) is a well-established method for treatment of medial Uni compartmental-knee osteoarthritis and correction of varus deformity(3).Double level osteotomy recently used as another method for treatment this problem to improve outcomes and decrease complication(4).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients that are indicated for surgery for medial compartment osteoarthritis only (medial joint line tenderness, varus tibiofemoral malalignment) with classification of Kellgren Lawrence grade (1/2/3)
  • Age between 40 _ 60 years
  • No associated bony fractures or deformities
  • No associated ligamentous functional instability
  • Varus more than or equal 15 degrees

排除标准

  • Age younger than 40 or older than 60 years
  • Secondary Arthritis (Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection)
  • Lateral Compartment OA or patellofemoral OA

结局指标

主要结局

Occurrence of joint line obliquity (JLO) in the two groups.

时间窗: Preoperative , three months postoperative , one year postoperative

Postoperative limb alignment using bilateral standing anteroposterior full-length views of both lower limbs

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abd Elgawad Mohamed Abd Elgawad Ahmed

Resident Doctor

Assiut University

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