跳至主要内容
临床试验/NCT04541342
NCT04541342已完成不适用

Second-look Arthroscopic Evaluation of Cartilage Regeneration After Medial Opening-wedge High Tibial Osteotomy

Assiut University4 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
4
主要终点
Arthroscopic assessment of cartilage regeneration after high tibial osteotomy

研究概览

简要总结

Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity.

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. Osteoarthritis of the knee is a common problem causing significant knee pain and disability. Medial compartment osteoarthritis is predisposed to by varus deformity of the knee. High tibial osteotomy is a well-established method for treatment of medial unicompartmental knee osteoarthritis and correction of varus deformity. It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space. The methods for اigh tibial osteotomy include opening-wedge osteotomy and closed wedge osteotomy. An opening-wedge osteotomy has become increasingly popular compared to the other technique. One of the disadvantages of this technique is that the plate is placed subcutaneously on the medial aspect of the proximal tibia. Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy. Few papers assessed regeneration of the articular cartilage after medial opening-wedge osteotomy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age younger than 65 years
  • Medial joint line tenderness
  • BMI less than 30
  • Varus tibiofemoral malalignment
  • Range of motion in the knee joint maintained from greater than 100 degrees of flexion to less than 15 degrees of flexion contracture
  • Osteoarthritis of the knee with any degree of cartilage damage provided that the cartilage damage in the lateral compartment not exceeding Outerbridge grade 2
  • No associated ligamentous functional instability

排除标准

  • Age older than 65 years
  • Severe Lateral compartment osteoarthritis (Outerbridge grade 3 or 4)
  • Flexion contracture of greater than 15 degrees
  • Inflammatory arthritis, post-traumatic osteoarthritis, active knee infection

结局指标

主要结局

Arthroscopic assessment of cartilage regeneration after high tibial osteotomy

时间窗: 6 months after high tibial osteotomy

By use of Outerbridge classification of chondral lesions during arthroscopy, comparison will be made between cartilage status before and after high tibial osteotomy according to the Outerbrigde classification which classifies cartilage lesions into grades of 0 through IV. Grade 0 signifies normal cartilage. Grade I chondral lesions are characterized by softening and swelling, which often require tactile feedback with a probe or other instrument to assess. Grade II lesion describes a partial-thickness defect with fissures that do not exceed 0.5 inches in diameter or reach subchondral bone. Grade III is fissuring of the cartilage with a diameter \> 0.5 inches with an area reaching subchondral bone. The most severe is Grade IV, which includes erosion of the articular cartilage that exposes subchondral bone.

次要结局

  • Post-operative limb alignment(6 months after high tibial osteotomy)

研究者

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

Ahmed Mohamed Sayed Mohamed

physician

Assiut University

研究点 (4)

Loading locations...

相似试验