跳至主要内容
临床试验/NCT01905358
NCT01905358终止不适用

Title: The Study of Intra-articular Interventions of Platelet Rich Plasma or Hyaluronic Acid Compounds vs. Usual Care (Exercise/Diet/Supplements) in the Medical Management of Knee OA- Effects on Pain and Function; Effects on Articular Cartilage; Effects on Time to Partial or Total Knee Arthroplasty: The Knee Usual Care Evaluation (KUCE) Study

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 906 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
906
试验地点
1
主要终点
Short Form (12) Health Survey (SF-12)

研究概览

简要总结

The purpose of this prospective data collection is to track patients who are treated at HSS who are confirmed with knee osteoarthritis. The registry will collect prospective patient related and functional outcomes (including use of assistive devices), medication use and imaging data on patients with confirmed osteoarthritis, and the effect of different medical interventions that include PRP, Synvisc / Orthovisc /Euflexxa, bracing, suggested exercises, supplements, and diet. Information from the data collection will be used to compare outcomes of non-surgical alternatives with the end point being knee arthroplasty. The information results will enhance our knowledge of the long-term efficacy and effectiveness of non-surgical interventions intended to treat the progression of osteoarthritis.

Hypotheses:

  • Different non-surgical interventions such as PRP, Synvisc®, Orthrovisc®, Euflexxa, bracing, physical therapy, and a prescribed combination of exercise, diet, and supplements will demonstrate statistically significant differences in patient pain and functional outcomes compared to usual interventions including use of NSAIDs, corticosteroid injections, and use of assistive devices such as canes.
  • Non-operative interventions for knee osteoarthritis will be associated with different rates of breakdown of articular cartilage and different rates of progression of osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?
  • Education about available non-operative treatment methods may change time the end point of total or partial knee replacement for patients with knee osteoarthritis of varying severity.
  • Different non-operative interventions will be associated with different times to total or partial knee arthroplasty in patient with knee osteoarthritis of similar severity.
  • An electronic data capture system (EDC) for osteoarthritis patients will improve patient care and patient outcomes.

详细描述

Specific Aims:

  • To ascertain the long term success of non-surgical interventions intended to alleviate symptoms or slow progression of osteoarthritis of the knee.
  • To ascertain if non-operative interventions for knee osteoarthritis improve patient pain, function, and quality of life.
  • To ascertain if non-operative interventions for knee osteoarthritis affect the breakdown of articular cartilage and slow progression of osteoarthritis as evidenced by MRI or joint space narrowing on standing knee films?
  • To ascertain the amount of time between the initial entry into care at HSS and the end point of total or partial knee replacement for patients with knee osteoarthritis of varying severity.
  • To ascertain if non-operative interventions for knee osteoarthritis prolong time to knee replacement surgery.
  • To implement at electronic data capture system (EDC) for osteoarthritis patients which will store validated patient reported outcomes, physical findings, and imaging results.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age greater than 30 years and less than 80 years
  • Knee pain for at least 6 weeks
  • Pain rate greater than or equal to 4/10 on a visual analog scale
  • Morning stiffness less than 30 minutes
  • Crepitus on active motion of the knee, bony tenderness, or bony enlargement of the knee
  • Willing and able to consider all medical treatment options used to manage osteoarthritis of the knee
  • No contraindications to knee radiographs or MRI
  • Willing to participate in a registry
  • Able to understand and sign a consent
  • Able to answer registry questions independently

排除标准

  • Diagnosis of a systemic rheumatic disease or crystalline arthritis (ie RA, SLE, systemic sclerosis, psoriatic arthritis or psoriasis, gout, pseudogout, lyme arthritis, reactive arthritis, viral arthritis
  • pregnant or nursing
  • unable to give informed consent
  • contraindication to MRI such as indwelling paemaker or cochlear implant
  • requirement of metal equipment (such as oxygen)
  • known claustrophobia
  • gadolinium allergy
  • lack of fluency in English. Unfortunately, we do not have the financial resources to offer full translation services

结局指标

主要结局

Short Form (12) Health Survey (SF-12)

时间窗: 6 months, 12 months, 24 months, 36 months, 48 months and 60 months.

Change is being assessed.

次要结局

  • Knee injury and Osteoarthritis Outcome Score (KOOS)(6 months, 12 months, 24 months, 36 months, 48 months and 60 months.)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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