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临床试验/NCT01264991
NCT01264991终止不适用

The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients - A Double-Blinded Randomized Placebo (Sham) Controlled Multi-Centre Trial

Slagelse Hospital4 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2011年2月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
41
试验地点
4
主要终点
Knee injury and Osteoarthritis Outcome Score - KOOS

研究概览

简要总结

BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and the knee is one of the most affected joints. The meniscus plays an important role in the development of knee OA. It is unclear whether a degenerative meniscus tear is a risk factor in developing knee OA or a sign of the disease. The standard treatment for a degenerative meniscus tear is an arthroscopic partial meniscectomy (APM). There is strong evidence that this puts the knee at high risk of later developing OA. Earlier studies have shown a significant placebo effect from surgical procedures, in general, and an arthroscopic knee procedure, in particular.

PURPOSE The overall purpose of this study is to gather information that might lead to a reduction in the development of OA in middle-aged patients. The investigators hypothesise that the benefit from an arthroscopic partial meniscectomy is due to the placebo effect measured on self-reported outcomes, and that the meniscectomy contributes to the development of knee OA as seen on radiography.

METHODS The investigators will include 100 patients aged from 35 to 55 years with an MRI-confirmed medial meniscus tear and without knee OA (excluding patients with Grade 3 or 4 knee OA on the Kellgren-Lawrence classification). Participants will be randomised to either a standard APM procedure or a sham procedure and both groups will receive standard post-operative care. The primary outcomes will be a self-reported questionnaire, the KOOS score, and a functionality test after 3 and 24 months.

详细描述

BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and affects 4.5 % of the Danish population. The knee is one of the most affected joints and 45 % of all OA-related hospital contacts are related to the knee. OA has a long 'pre-clinical' phase with joint changes without symptoms. Then comes a symptomatic phase with pain and functional limitations. This is sometimes accompanied by structural changes visible on plain X-ray examination and other pathological changes like focal areas of damage to the articular cartilage, centered on load-bearing areas. After this, new bone formation at the joint margins (osteophytosis) develops along with changes in the subchondral bone, variable degrees of mild synovitis, and thickening of the joint capsule.

The meniscus plays an important role in the development of osteoarthritis. Meniscus tears can be both a risk factor for knee OA as well as a sign of disease . Both meniscus injury and a meniscectomy contribute to the development of knee OA. The surgical removal of the damaged parts of a meniscus tear puts the knee at high risk of later developing OA . Surgical resection also leads to increased joint cartilage contact stress through altered load transmission, decreased shock absorption, and decreased joint stability .

The current standard treatment for a degenerative meniscus tear is arthroscopic partial meniscectomy (APM). Arthroscopic surgery is one of the most frequent orthopaedic procedures with approximately 10,000 APM procedures being done per year in Denmark .

The benefit from an APM procedure is, however, uncertain and needs to be further investigated. As mentioned above, it significantly increases the risk of developing knee OA. The investigators also know that a significant placebo effect is present in arthroscopic knee surgery including the APM procedure . It has furthermore been shown that patients with a degenerative meniscus tear can recover without surgery and by exercise alone , . The recovery period after an APM procedure is also much longer than most surgeons realize, with disability still evident after 3 months.

The investigators need to investigate the placebo effect in younger patients with a degenerative meniscus tear but without knee OA by implementing additional well-designed, randomized, placebo controlled trials to reveal the true effects of the APM procedure on a short-and long-term basis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
35 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with knee pain for more than 2 months without significant trauma (only the index knee will be included)
  • MRI-confirmed medial meniscus lesion (patients with a medial meniscus lesion AND a lateral lesion will also be included)
  • Age 35-55 years*
  • Eligible for outpatient surgery - ASA score 1-2

排除标准

  • Patients in need of acute surgery e.g. locking knees, high-energy trauma
  • Symptoms associated with other musculoskeletal co-morbidities overriding the symptoms of the knee
  • Grade 3 or 4 knee OA on the Kellgren-Lawrence classification
  • Knee surgery within the last 2 years
  • Obese patients with BMI > 35
  • Patients with ischemic heart disease
  • Patients with diabetic late-complications
  • Patients with thrombophilia
  • Patients unable to speak Danish
  • Patients with drug or alcohol abuse

研究组 & 干预措施

APM group

Experimental

干预措施: Arthroscopic partial meniscectomy (Procedure)

Sham group

Placebo Comparator

干预措施: Sham procedure (Procedure)

结局指标

主要结局

Knee injury and Osteoarthritis Outcome Score - KOOS

时间窗: 2 year follow-up

The primary outcome at 2 years follow-up will be a self-reported questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), comprising five different subscales: 1. pain 2. other symptoms 3. activities in daily living (ADL) 4. function in sport and recreation 5. knee-related quality of life (QOL) A mean of the 5 subscales will be calculated (KOOS5 = \[KOOSpain + KOOSsymptoms + KOOSADL + KOOSsport\&rec KOOSQOL\] / 5. Range 0 to 100, worst to best)

次要结局

  • EQ-5D(2 year follow-up)
  • Knee extension strength(2 year follow-up)
  • Knee-bending test(2 year follow-up)
  • One-leg jump test(2 year follow-up)
  • Development of knee osteoarthritis(5 year follow-up)
  • SF-36(2 year follow-up)

研究者

发起方
Slagelse Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristoffer Hare

MD

Slagelse Hospital

研究点 (4)

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