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临床试验/NCT04056845
NCT04056845Unknown不适用

Prospective Randomized Study on the Effects of Valgus Knee Brace for Knee Osteoarthritis in Chinese Patients

Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Improvement in pain

研究概览

简要总结

To investigate whether the use of valgus knee brace is useful for patients with medial knee osteoarthritis.

详细描述

Osteoarthritis of the knee is the commonest type of arthritis affecting both the middle age and geriatric population, which poses a huge burden to our in-patient and out-patient orthopaedic services. Conservative treatment like physiotherapy and analgesic provide temporary symptomatic relief. Surgical treatment like high tibial osteotomy and knee arthroplasty are not without major potential surgical risks and implant-related complications.

Orthotic treatment can theoretically alter the loading to the knee joint and help to reduce the symptoms and disease progression. Small scale biomechanical studies have demonstrated such effects with the use of valgus knee brace (2-4). Though prospective clinical outcome studies on Chinese patients in our locality are lacking.

Valgus knee brace is a non-pharmaceutical, non-invasive option for knee pain. Using a three-point leverage the unloader brace is to shift the stress away from the arthritic area to the normal portion of the knee, maintains good alignment and stability and thus provides significant pain relief during daily activities. It has been commonly used as a first line management option in other countries.

Our aim is to perform a prospective randomized study to look at the difference in outcome measures in osteoarthritic patients with the use of valgus knee brace, on top of the usual regime of conservative treatment.

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
Double (Investigator, Outcomes Assessor)

盲法说明

Outcome assessors are blinded from the treatment received

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 40-80
  • History of symptomatic medial unicompartmental knee osteoarthritis > 6 months
  • Willingness to wear the knee brace for a minimum of 4 hours per day during daily activities
  • Understanding of the Chinese language
  • Ethnic Chinese patients

排除标准

  • Symptomatic knee osteoarthritis affecting more than one compartment
  • Clinical and radiological signs of osteoarthritis over the lateral compartment or patello-femoral joint
  • Significant knee effusion or soft tissue compromise preventing long-term knee brace use
  • Obesity (BMI>30)
  • Previous surgery on the affected knee other than diagnostic arthroscopy with debridement, soft tissue reconstruction, menisectomy
  • Peripheral vascular disease of the lower limb

研究组 & 干预措施

Knee brace group

Experimental

Patients in this group will receive a valgus knee brace (Medex K39-OA Corrector), to be worn for at least four hours a day, during the study period, on top of the presrciption of physiotherapy and oral analgesic (diclofenac and panadol).

干预措施: Valgus knee brace (Medex K39-OA Corrector) (Device)

Knee brace group

Experimental

Patients in this group will receive a valgus knee brace (Medex K39-OA Corrector), to be worn for at least four hours a day, during the study period, on top of the presrciption of physiotherapy and oral analgesic (diclofenac and panadol).

干预措施: Physiotherapy and oral analgesic (diclofenac and panadol) (Other)

Control Group

Active Comparator

Patients in this group will receive physiotherapy and oral analgesic (diclofenac and panadol).

干预措施: Physiotherapy and oral analgesic (diclofenac and panadol) (Other)

结局指标

主要结局

Improvement in pain

时间窗: At 16 weeks after the initiation of study

Visual Analog Scale (VAS) for pain from 0 to 10, with higher value signifying worse pain control

次要结局

  • Improvement in knee functioning(At 16 weeks after the initiation of the study)

研究者

发起方
Hospital Authority, Hong Kong
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Keith Hay-Man Wan

Resident Specialist

Hospital Authority, Hong Kong

研究点 (1)

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