Safety and Effectiveness of Hyaluronic Acid and Sorbitol With Overuse Knee Pain in Sportsmen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain.
详细描述
Sports activities have become a fundamental part of our daily life, this has led to an overuse of load joints, being the knee the most relevant. Overuse injuries of the knee result from microtrauma associated with physical activity and exercise that exceeds the strength of the cartilage tissue.
The purpose of this study is to evaluate the usefulness and safety of hyaluronic acid in athlete patients with knee overuse syndrome. Investigators hypothesis is that hyaluronic acid y safe and can improve symptoms of knee pain in sports patients. . Scores recorder data will be made at 15 days, then at 3 and 6 months after two knee injections of hyaluronic acid with sorbitol (Synolis VA).
Synolis VA is a viscoelastic, sterile, non-pyrogenic, isotonic, buffered solution of 2% hyaluronic acid. The hyaluronic acid used in synolis VA is obtained from bacterial fermentation and has a high molecular weight of 2 mdaltons, it has a neutral pH of 6.8 - 7.4 like synovial fluid. High concentration and high molecular weight of hyaluronic acid combined with sorbitol limits its degradation and confers the capacity of viscoelastic solution to restore joint lubrication and shock absorption properties.
This research protocol has been approve by the ethics and research Institutional committee in ISSEMyM Tlalnepantla Estado de Mexico number: CEI/0504/PI./2022. All participants must sign a informed consent to confirm be part fo this study.
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
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients with knee pain for more than 3 months
- •Patients between 30 and 55 years old
- •Patients without a history of previous knee joint surgery.
- •Patients without chronic-degenerative diseases such as diabetes, hypertension, rheumatoid arthritis or other autoimmune diseases.
- •Patients who perform impact social sports at least 3 times a week for more than 1 hour in the last 3 months prior to treatment.
- •Patients without a history of allergies to non-steroidal anti-inflammatory drugs.
- •Patients with no history of infection in or around the knee.
排除标准
- •- Patients who cannot be categorized as social athletes.
- •Patients with an associated sports injury that limits their sports practice.
- •Patients who have a treatment associated with knee pain independent of that established in the study protocol.
研究组 & 干预措施
Hyaluronic Acid group
All overuse knee syndrome participants after both knee joint infiltration with two doses each of Synolis VA (2ml = 40 milligrams of hyaluronic acid with 80 milligrams of sorbitol).
干预措施: KNEE JOINT INFILTRATION WITH HYALURONIC ACID WITH SORBITOL SYNOLIS VA (Drug)
结局指标
主要结局
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Baseline, 15 days, 3 months, and 6 months
To demonstrate that two doses of intra-articular injection of Synolis VA® for the overuse knee syndrome in sportsmen decrease the pain during spots and day-living activities by measured the improvement of knee symptoms through the KOOS score: - The Knee injury and Osteoarthritis Outcome Score: Evaluate Symptoms + Stiffness subtotal, Pain, Function, daily living, sports and recreational activities and quality of life. Each variable has a percentage score from 0 to 100%, at the end the results are averaged, obtaining a final percentage where 100% means a healthy knee with out discomfort. As the percentage approaches 0%, the severity of knee discomfort or injury increases.
Efficacy of Hyaluronic Acid With Sorbitol (SYNOLIS VA) in Overuse Knee Syndrome Assessed With the International Knee Documentation Committee Score (IKDC)
时间窗: Baseline, 15 days, 3 months, and 6 months
To evaluate the effectiveness of two intra-articular injections of Synolis VA in improving knee functionality in athletes with overuse knee syndrome, the International Knee Documentation Committee (IKDC) Scale was used. This validated tool assesses knee function, symptoms, and the ability to perform sports-related activities. It consists of individual items evaluating pain, stiffness, swelling, instability, daily physical function, and athletic performance. While the scale's raw score ranges from 0 to 87, results are converted into a percentage format, where 87 corresponds to 100% functional capacity-the best possible knee function-and 0 represents the worst condition."
次要结局
- Safety of Hyaluronic Acid With Sorbitol (SYNOLIS VA ®) in Overuse Knee Syndrome by the Number of Adverse Effects in Participants.(6 months)
- Six-Month Functional Improvement in Knee Function (IKDC and KOOS) in Athletes With Overuse Knee Syndrome With Elevated BMI Following Synolis VA Injections(6 months post-treatment)
研究者
Julio Carlos Velez de Lachica
Head of orthopedic surgery department
Hospital Regional Tlalnepantla