Hydrolyzed Collagen Formulation Versus Placebo in the Treatment of Degenerative Knee Cartilage Injuries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- KOOS-Pain Score
研究概览
简要总结
The aim of the study is to compare the 6 months clinical outcome of the treatment with a single intra-articular collagen injection versus a single placebo (saline solution) infiltration in the infiltrative treatment of knee osteoarthritis. The evaluation will be performed through clinical, subjective and objective assessments.
详细描述
204 patients affected by knee osteoarthritis will be included in a double-blinded randomized controlled trial. Patients in the experimental group will be treated with a single intra-articular injection of collagen (solution of low molecular weight peptides derived from hydrolyzed collagen) instead patients in the control arm, will be treated with a single intra-articular injection of placebo (saline solution). All patients will be evaluated by clinical examination before the infiltrative procedure and they will follow-up at 1,3,6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment and questionnaires, filled out by patients, will be utilized for clinical evaluations. After 6 months, patients in the control arm (saline solution injection), have the possibility to cross-over into the treatment arm (collagen) in which case they will be followed for an additional 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
his is a double-blind randomized controlled trial with 1:1 allocation. Patients, healthcare professionals who assess clinical and functional outcomes (outcome assessors) and professionals who analyze the data will be "blinded."
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral involvement;
- •Signs and symptoms of degenerative pathology of knee cartilage;
- •Radiographic and MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
- •Failure, defined as the persistence of symptoms, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
- •Ability and consent of patients to actively participate in clinical follow-up;
排除标准
- •Patients who have undergone intra-articular injections of another substance in the previous 6 months;
- •Patients undergoing knee surgery within the previous 12 months;
- •Patients with malignant neoplasms;
- •Patients with rheumatic diseases;
- •Patients with diabetes;
- •Patients with hematologic diseases (coagulopathies);
- •Patients on anticoagulant therapy;
- •Patients with metabolic disorders of the thyroid gland;
- •Patients abusing alcoholic beverages, drugs or medications;
- •Body Mass Index > 35;
- •Pregnant or lactating women.
- •Patients with established hypersensitivity to bovine collagen or vitamin C.
- •Patients with joint or peri-articular infections, emarto, erythema, or psoriatic patches in the knee joint area
研究组 & 干预措施
Collagen Injection
This group of patients will be treated with single intra-articular injection of collagen.
干预措施: Collagen (Procedure)
Placebo (saline solution)
This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months.
干预措施: Placebo (saline solution) (Procedure)
结局指标
主要结局
KOOS-Pain Score
时间窗: 6 months follow-up
KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain"
次要结局
- KOOS Score(baseline, 1 month, 3 months, 6 months follow-up)
- Final treatment opinion(6 months follow-up)
- Patient Acceptable Symptom State (PASS)(baseline, 1 month, 3 months, 6 months follow-up)
- Thermographic evaluation of the inflammatory status of the knee joint(baseline, 1 month, 3 months, 6 months follow-up)
- IKDC-Subjective Score(baseline, 1 month, 3 months, 6 months follow-up)
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score(baseline, 1 month, 3 months, 6 and 12 months follow-up)
- VAS-pain (Visual Analogue Scale)(baseline, 1 month, 3 months, 6 months follow-up)
- TegnerActivity Level Scale(baseline, 1 month, 3 months, 6 months follow-up)
- Objective parameters -Range of motion(baseline, 1 month, 3 months, 6 months follow-up)
- Ultrasound assessment(Baseline)
- EQ-VAS(baseline, 1 month, 3 months, 6 months follow-up)
- EQ-5D (EuroQoL) Current Health Assessment(baseline, 1 month, 3 months, 6 months follow-up)
- Objective parameters - Circumferences(baseline, 1 month, 3 months, 6 months follow-up)