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临床试验/NCT02113280
NCT02113280撤回不适用

Randomised Controlled Trial Comparing Arthroscopy With Physiotherapy for Degenerative Meniscal Tears

Northumbria Healthcare NHS Foundation Trust2 个研究点 分布在 1 个国家开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in Knee injury and Osteoarthritis Outcome Score

研究概览

简要总结

Patients with wear and tear in their knees (osteoarthritis) are often referred to orthopaedic surgeons following a sudden worsening of pain and mechanical symptoms (grinding, locking, giving way) in their knee due to tears of their meniscal cartilages. These tears are described as degenerative as they are not usually caused by a single injury but rather accumulation of wear and tear. It is not clear from the current available evidence what the best treatment for these patients is. Their underlying arthritis is not bad enough to require joint replacement yet and they were usually managing well with minimal problems from their knee until experiencing the meniscal tear. However, some of their symptoms are likely to be due to the arthritis rather than just the tear. Current treatment for these patients is usually in the form of conservative treatment with physiotherapy and supervised exercise or using arthroscopy (key-hole surgery) to trim the damaged area of the meniscus. We know from previous research that most of these patients will improve over time to some extent but it is not clear whether a greater improvement can be expected following surgery and if so, whether this applies to all patients with this problem or not.

Our study is intended to compare the outcome of patients with proven degenerative meniscal tears imaged on MRI scans, when they are assigned to arthroscopy followed by supervised exercise or supervised exercise alone. They will be randomly assigned and the outcome will be assessed using patient-completed questionnaires (Knee Outcome Osteoarthritis and injury Score [KOOS], SF12, visual analogue score for pain) and whether the patients go on to require further surgery during the period of the trial. The patients will be assessed at baseline, at 6 weeks, 6 months, 12 months and 24 months.

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
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 45 years
  • Knee pain in the presence of a medial meniscal tear on MRI.

排除标准

  • History of trauma to the knee or ipsilateral lower limb in the past 2 years
  • Inability to engage in postoperative rehabilitation
  • Lacking capacity to consent
  • Evidence of infection
  • Previous knee surgery other than arthroscopy (diagnostic or partial meniscectomy) Neurological disease
  • Inflammatory arthritis
  • Loose bodies
  • Ligament injuries causing symptomatic instability
  • Women who are pregnant
  • Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
  • Uncontrolled disease states, such as moderate/severe asthma, COPD or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids, or recurrent infections.

结局指标

主要结局

Change in Knee injury and Osteoarthritis Outcome Score

时间窗: 6weeks, 6 months, 12 months, 24 months

Patient completed outcome measure

次要结局

  • SF12(6 weeks, 6 months, 12 months, 24 months)
  • Pain visual analogue score(6 weeks, 6 months, 12 months, 24 months)

研究者

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

Sarah Johnson-Lynn

Specialty Registrar

Northumbria Healthcare NHS Foundation Trust

研究点 (2)

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