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临床试验/NCT06251752
NCT06251752招募中不适用

Long Term Evaluation of Clinical and Radiologic Results on Femoro-patellar Joint After High Tibial Osteotomy

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
patellar height

研究概览

简要总结

Osteotomies are among the oldest orthopedic treatments, in use for over 2000 years and still commonly employed. The basic principle involves making a bone cut to allow the realignment of the limb segment affected by deformity. Today, new knowledge and technologies, understanding of bone healing mechanisms, and the introduction of new fixation methods have made osteotomies one of the preferred treatments for early knee arthritis. They serve as an alternative to joint prosthesis implantation in young patients with medium to high functional demand.

Medial knee osteoarthritis is a pathology increasingly prevalent in today's population. The resulting varus deformity leads to a shift in the load axis on the medial tibial plateau. Osteotomy in this context becomes a therapeutic tool capable of restoring the correct mechanical axis of the lower limb and delaying or avoiding the progression of arthritis, thus avoiding the need for joint replacement.

The two most commonly used techniques are the Closing Wedge Lateral High Tibial Osteotomy (LCW-HTO) and the Opening Wedge Medial High Tibial Osteotomy (MOW-HTO), which are high tibial osteotomies in closure with a wedge removal and in opening with a wedge insertion, respectively.

The medium to long-term effects of this procedure, in terms of survival and modification of the tibial slope, have been extensively studied, as evidenced by the extensive literature on the subject. However, the effect of this intervention, in its two variants, on the progression of femoro-patellar arthritis and the height of the patella remains poorly investigated to date.

研究设计

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

入排标准

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

入选标准

  • •Diagnosis of medial unicompartmental knee osteoarthritis (Outerbridge III-IV)
  • •Follow-up > 60 months
  • •Completeness of clinical and radiographic documentation.
  • •Previous valgus osteotomy procedure (MOW-HTO or LCW-HTO)
  • •Age <65 years

排除标准

  • •Patients with previous injuries affecting the involved lower limb.
  • •Patients with prior traumatic, septic, and rheumatoid arthritis.
  • •Patients with previous alterations of the patellofemoral joint.
  • •Patients with knee ligament injuries.
  • •Patients with confirmed neuromuscular disorders or psychomotor disturbances.
  • •Patients with congenital generalized hypermobility syndrome.
  • •Patients with severe pathologies in other organs or systems limiting activities of daily living (ADL).
  • •Patients who refuse to participate in the study.

研究组 & 干预措施

Lateral closing wedge high tibial osteotomy

Active Comparator

干预措施: X-rays: load bearing inferior limbs, lateral knee, axial patella (Diagnostic Test)

Medial opening wedge high tibial osteotomy

Active Comparator

干预措施: X-rays: load bearing inferior limbs, lateral knee, axial patella (Diagnostic Test)

结局指标

主要结局

patellar height

时间窗: baseline time 0

RX measurement of patellar height

femoral-patellar arthritis

时间窗: baseline time 0

RX evaluation of femoral-patellar arthritis

次要结局

  • Kujala score(baseline time 0)
  • Knee injury and Osteoarthritis Outcome Score(baseline time 0)
  • Range of Motion(baseline time 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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