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临床试验/NCT01557868
NCT01557868已完成4 期

Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis

American Orthopaedic Society for Sports Medicine1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2008年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
198
试验地点
1
主要终点
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale

研究概览

简要总结

The purpose of this study is to evaluate whether the investigators can develop a computer algorithm to predict which individual patients will respond to injections of hyaluronic acid (HA) products for knee osteoarthritis.

详细描述

Background Osteoarthritis (OA) of the knee is a debilitating condition that affects an estimated 21 million Americans. This number is expected to rise steadily as the population ages. The medical expenditures associated with arthritis and other rheumatic conditions in the United States have increased from $50 billion in 1997 to $86 billion in 2003. In 2003, almost 420,000 total knee replacements were performed, primarily for arthritis. Injections of hyaluronic acid (HA) have been shown to provide symptom relief for many OA patients who have failed to respond to conservative interventions. Many other patients, however, experience only slight or no improvement. The results from this study will allow physicians to identify whether a patient is likely or not likely to respond well to HA therapy leading to improved treatment success rates.

Goals This study has two related goals: 1) to identify patient and treatment factors that predict response to intra-articular injections of hyaluronic acid for knee osteoarthritis using multivariable analysis and 2) develop mathematical and statistical models that will predict individual patient response to HA for knee OA.

It is anticipated that the investigators will develop computer software in this study that can support clinical decision making related to viscosupplementation in the treatment of knee OA. If this project yields successful patient predictive models, physicians who are considering a trial of HA for a patient will have some empirical basis for treatment selection. Eventually a physician would be able to assess a relatively small number of variables for a patient and then be provided with predictions regarding treatment response.

**Please note that the study site at the Naval Medical Center in Portsmouth, Virginia can only enroll patients who are eligible to be treated at a military facility.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • •Symptomatic knee osteoarthritis presenting to physician's office
  • •Radiographic evidence of knee osteoarthritis
  • •Age 18 years or older
  • •Failed minimum of 3 months of non-operative treatment, including, but not limited to, Tylenol, anti-inflammatory medication, cortisone injection, physical therapy, bracing, and/or heel wedge
  • •Symptoms for at least 3 months

排除标准

  • •Associated ligamentous instability
  • •History of deep knee infection
  • •Candidate for total knee arthroplasty or arthroscopy
  • •Peripheral neuropathy.
  • •X-rays that are completely negative and only MRI evidence or arthroscopic evidence (from previous arthroscopy) of OA.
  • •Prior HA injections at any point in the past
  • •Chondrocalcinosis
  • •Patients with precautions or contraindications for viscosupplementation use
  • •Cortisone injection within past 3 months

研究组 & 干预措施

Euflexxa (1% sodium hyaluronate)

Active Comparator

干预措施: 1% sodium hyaluronate (Device)

Synvisc (hylan G-F 20)

Active Comparator

干预措施: hylan G-F 20 (Device)

结局指标

主要结局

Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Scale

时间窗: Baseline and at 6 month follow-up

The KOOS is 42-item patient-report questionnaire that assesses symptoms and problems associated with knee injury and osteoarthritis. It yields scores for five scales including Pain, Other Symptoms, Function in Daily Living, Function in Sport/Recreation, and Knee-Related Quality of Life. We used only the Pain scale which has a range of 0 to 100 where 100 represents the "best" score, i.e., no pain. We reported differences in baseline Pain scale score from Pain scale score at 6 months so these scores could theoretically range from -100 (moving from no pain to maximum pain) to 100 (moving from maximum pain to no pain). Positive change scores represent improvement from baseline.

次要结局

  • Visual Analogue Scale (VAS) at 6 Months(Assessments were at baseline to 6 month follow-up)

研究者

发起方
American Orthopaedic Society for Sports Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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