A Double Blind, Randomized Post Marketing Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hyaluronic Acid on Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 100mm VAS (Visual Analogue Score)
研究概览
简要总结
This study was designed to assess the efficacy for pain relief, functional improvement, and safety of intra-articular collagen injections compared to hyaluronic acid injections for knee osteoarthritis.
详细描述
This is a double-blind study involving 100 participants. After receiving an explanation of the study and voluntarily providing written informed consent, subjects underwent a screening process to confirm eligibility. Eligible subjects were randomly assigned to receive an intra-articular injection of either collagen or hyaluronic acid. To maintain the double-blind design, the intra-articular injection was administered by a separate unblinded injector. During the study period, subjects were required to follow the investigator's instructions. According to the study protocol, subjects participated in the study for 12 months from enrollment. A total of six hospital visits were conducted, including a screening visit, an enrollment/injection visit, visits at 4 and 12 weeks after injection, and follow-up visits at 24 and 52 weeks. At each visit, efficacy was evaluated according to the clinical trial protocol through questionnaire assessments and blood tests, and safety was assessed by monitoring adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Patients with knee pain due to osteoarthritis (OA)
- •Patients with Kellgren-Lawrence grade 3 or less
- •Patients with a 100 mm VAS pain level of 40 mm or greater
- •Patients without clinically significant clinical pathology test results during the screening period
- •Patients who confirmed accurate prescription records for medications taken within at least one week before the study and agree to maintain the same dosage of concomitant medications as before the injection if such medications are continuously administered during the study period
- •If taking concomitant medications, patients who have been on stable medication for approximately two weeks before participating in the study, considering the duration of drug maintenance in the body (stability must be confirmed one week before screening and reconfirmed at the time of registration when the injection is applied to ensure two weeks of stable medication use)
- •Rescue analgesic medications administered within one week of intra-articular injection are allowed (given to the subject after injection), provided that if additional analgesics are required due to increased pain at the observation site, patients should agree not to use more than 5 consecutive days or 10 days per month, and to stop taking analgesics at least 2 days before the next visit.
- •Patients who agree to undergo only non-drug therapies (physical therapy, osteopathy, chiropractic care) as allowed by a clinician (excluding acupuncture)
- •Patients who agree to have the injection administered to the more painful knee if both knees are affected (intra-articular injections in the contralateral knee are prohibited)
- •Patients or their legal representatives who consent to participate in the study and sign the written informed consent form
排除标准
- •Patients with ongoing or past autoimmune diseases, either personally or in their family
- •Patients with a history of anaphylactic reactions
- •Patients with hypersensitivity to implants
- •Patients with hypersensitivity to porcine protein
- •Patients with a Kellgren-Lawrence grade of 4
- •Patients with severe effusion
- •Patients who had a serious injury or received an injection in the affected knee that may interfere with evaluation within 6 months prior to screening
- •Patients with inflammatory arthritis, such as rheumatoid arthritis, lupus arthritis, or psoriatic arthritis (except when deemed eligible for collagen administration by the clinician)
- •Patients with gout or pseudogout diagnosed within 6 months prior to screening (except when deemed eligible for collagen administration by the clinician)
- •Patients with a history of radiation or chemotherapy within the past 2 years (except when deemed eligible for collagen administration by the clinician)
- •Diabetic patients (except those who maintain normal blood sugar levels, have no complications related to diabetes, and are deemed eligible for collagen administration by the clinician)
- •Patients with infections receiving treatment with antibiotics or antimicrobials that require hospitalization (except when deemed eligible for collagen administration by the clinician)
- •Patients receiving adrenocortical hormone therapy (except when deemed eligible for collagen administration by the clinician)
- •Patients with heart, liver, or kidney diseases (except those maintaining normal test results or deemed clinically insignificant by the clinician, in which case collagen administration is allowed; hypertension excluded)
- •Patients with viral infections (except those maintaining normal test results or deemed clinically insignificant by the clinician, in which case collagen administration is allowed)
- •Patients with any clinically significant medical condition that may affect the completion of the study
- •Patients who are pregnant, breastfeeding, or planning to become pregnant
- •Patients with mental illness or others deemed inappropriate for the study by the study staff
- •Patients scheduled for surgery during the study period
研究组 & 干预措施
CartiZol
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.
干预措施: CartiZol (Device)
Synovian inj. (Hyaluronic acid)
Their eligibility to participate in the study is checked, and they are randomized into the intra-articular hyaluronic acid injection group based on a randomization table.
干预措施: Synovian inj. (Drug)
结局指标
主要结局
100mm VAS (Visual Analogue Score)
时间窗: Screening to 12 weeks post-injection
The change in the VAS score of the affected knee between screening and 12 weeks post-injection will be compared between the test group and the control group.
Visual Analogue Scale (VAS) for Pain (0-100 mm)
时间窗: From screening to 12, 24, and 52 weeks post-injection
1. Efficacy Evaluation Analysis The change in the VAS score of the affected knee between screening and 12 weeks post-injection will be compared between the test group and the control group. 2. Follow-up Evaluation Analysis The changes from baseline (screening) to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups. Scale description: 0 = no pain, 100 = worst imaginable pain (higher scores indicate worse pain)
次要结局
- 100mm VAS (Visual Analogue Score)(Screening to 4 weeks post-injection)
- WOMAC (The Western Ontario and McMaster Universities Arthritis Index)(Screening to 4 and 12 weeks post-injection)
- SF-36 (36-ltem Short-Form Health Survey)(Screening to 4 and 12 weeks post-injection)
- Participant satisfaction(4 and 12 weeks post-injection)
- Investigator satisfaction(4 and 12 weeks post-injection)
- X-ray examination(12 weeks post-injection)
- Biomarker test(Screening to 12 weeks post-injection)
- Visual Analogue Scale (VAS) for Pain (0-100 mm)(From screening to 4, 12, 24, and 52 weeks post-injection)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(From screening to 4, 12, 24, and 52 weeks post-injection)
- Short Form-36 Health Survey (SF-36)(From screening to 4, 12, 24, and 52 weeks post-injection)
- Participant satisfaction(At 4, 12, 24, and 52 weeks post-injection)
- Investigator satisfaction(At 4, 12, 24, and 52 weeks post-injection)
- X-ray examination (Kellgren-Lawrence Grade 1-4)(At 12, 24, and 52 weeks post-injection)
- Biomarker test(From screening to 12, 24, and 52 weeks post-injection, and at 12, 24, and 52 weeks post-injection)