NCT04661111已完成不适用
Prospective, Monocentric, Study to Assess Efficacy and Safety of Hymovis® ONE (32 mg/4 ml) Intra-articular Injection in Active Patients Affected by Knee Overuse Syndrome
Fidia Farmaceutici s.p.a.2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年6月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- The efficacy of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteoarthritis due to overuse: KOOS questionnaire (Knee injury and Osteoarthritis Outcome Score)
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.
详细描述
There are no studies in literature up to now, that analyze the changes in knee pain and correlate this parameter with knee function and biomechanics, in regular casual sport player subject affected by knee overuse syndrome and underwent an intra-articular HA injection. The aim of this study is to evaluate efficacy and safety of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteochondral lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female higher than 18 and less or equal to 65 years of age
- •an active life-style, professional or regular casual sport player (people who plays sport or trains themselves at least 2-3 times per week).
- •diagnosis of knee osteoarthritis will be based upon a standing weight bearing knee X-ray at Screening or an X-ray performed within 6 months prior to screening. The radiograms must be classified as a Kellgren and Lawrence Grade I-III for osteoarthritis of the knee.
- •a knee VAS pain score, within 48 hours before the visit.
- •patients must have had all analgesic/anti-inflammatory drugs discontinued for 2 weeks prior to Baseline except for acetaminophen.
排除标准
- •Major injury to the contralateral knee or other weight-bearing joint if it would interfere with the study assessments.
- •Surgical procedure of the studied joint within the previous 12 months prior to Screening.
- •Ligament reconstruction in the target knee within 1 year
- •Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis
- •Intra-articular or local peri-articular corticosteroid injections to the study joint/knee within the previous 3 months prior to screening or to any other joint (beside the study joint) or soft tissue area within the previous month prior to Screening.
- •Any corticosteroid within the previous month. Steroid inhalants are permitted if the patient has been on a stable regimen for the past month prior to Screening and remains on this regimen throughout the course of the trial.
- •Intra-articular hyaluronan in the studied joint within the previous 6 months prior to Screening.
- •History of allergic reaction to an intra-articular Hyaluronic acid injection
- •Use of glucosamine- or chondroitin sulfate-containing products unless the patient is on stable doses for at least 4 months prior to Screening and willing to remain on these stable doses throughout the course of the trial.
- •Patients with X-ray findings of acute fractures, severe loss of bone density, avascular necrosis and/or severe deformity.
- •Axial deviation of the lower limbs higher than 20 degrees in valgus or varus on standing X-ray.
- •Symptomatic osteoarthritis of either hip, contralateral knee or spine that may interfere with functional assessment of the signal knee.
- •Clinically significant medio-lateral and/or anterior-posterior instability.
- •Osteonecrosis of either knee.
- •If patients are receiving or performing physical therapy at Screening, this physical therapy regimen has not been stable during the one-month preceding Screening and the patient is not willing to maintain the same regimen throughout the course of the trial.
- •Patients with Kellgren-Lawrence Stage IV osteoarthritis of the knee (i.e.,in grade IV large osteophytes, marked narrowing, severe sclerosis, and definite deformity).
- •Hemiparesis of the lower limbs
结局指标
主要结局
The efficacy of Hymovis® ONE (32 mg/4 ml) single intra-articular injection, in the management of pain caused by knee osteoarthritis due to overuse: KOOS questionnaire (Knee injury and Osteoarthritis Outcome Score)
时间窗: Day 90 after baseline visit
To demonstrate that a single intra-articular (i.a.) injection of Hymovis® ONE (32 mg/4 ml) decreases the difficulties in sport and recreational activity. The efficacy will be measured evaluating the improved knee function during sport and recreational activity through the fourth item (SP1-SP5) of the KOOS questionnaire, 90 days after injection. A five-point Likert scale(LK3 series) will be used to score each of the five KOOS questionnaire items (Symptoms, Pain, Function daily living, Function in sports and recreational activities).
次要结局
- Biomechanical kinematic parameters through gait analysis( tilt at heel contact evaluated per each visit reported((Day 0, Day 30, Day 90, Day 180))
- Biomechanical kinematic parameters through gait analysis( flexion-evaluated evaluated per each visit reported )((Day 0, Day 30, Day 90, Day 180))
- Knee function through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) C scale.((Day 0, Day 30, Day 90, Day 180 and Day 360))
- Gait analysis system((Day 0, Day 30, Day 90, Day 180))
- Knee pain through WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) A scale.((Day 0, Day 30, Day 90, Day 180 and Day 360))
- Knee pain through Visual Analogical Scale (VAS, 100 mm, where "No pain = 0" while "Worst Pain Imaginable = 100")((Day 0, Day 30, Day 90, Day 180 and Day 360))
- Knee pain, function, stiffness and quality of life through KOOS ((Knee injury and Osteoarthritis Outcome Score) questionnaire.((Day 0, Day 30, Day 90, Day 180 and Day 360))
- Biomechanical kinematic parameters through gait analysis( tilt RoM evaluated per each visit reported in the time frame).((Day 0, Day 30, Day 90, Day 180))
- Biomechanical kinematic parameters through gait analysis(flexion-extension evaluated per each visit reported in the time frame).((Day 0, Day 30, Day 90, Day 180))
- Biomechanical kinematic parameters through gait analysis(RoM evaluated per each visit reported in the time frame).((Day 0, Day 30, Day 90, Day 180))
- The requirement for daily rescue analgesic medication (simple analgesics, acetaminophen) for pain relief. The "rescue dose" will be acetaminophen 3 g per day.((Day 0, Day 30, Day 90, Day 180 and Day 360))
- Biomechanical kinematic parameters through gait analysis(rotation RoM evaluated per each visit reported )((Day 0, Day 30, Day 90, Day 180))
- The safety of a single i.a. injections by tracking the number of patient withdrawals and their adverse events((Day 30, Day 60, Day 90, Day 135, Day 180, Day 270 and Day 360))
研究者
研究点 (2)
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