Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Score change of 100 mm VAS
研究概览
简要总结
The primary objective of this study is to confirm the superiority of intra-articular collagen injection in patients with knee joint pain compared to the control group. 100mm VAS is used to measure the pain of the subjects 24 weeks after the procedure.
详细描述
This study is a double-blind, randomized clinical trial. Two hundred subjects has participated in it. The study is explained to the subjects, and they voluntarily choose to participate in it. Their eligibility to participate in the study is checked, and they are randomized either into the intra-articular collagen injection group or the normal saline (placebo) injection group based on a randomization table. They are asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects will undergo an examination with doctors, a medical examination by interview, and a blood test only when it is necessary to evaluate the safety and efficacy of the injection.
(*If the subjects performed the screening during the first visit on, the total number of his or her additional visits is four.)
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
- 是
入选标准
- •Adult patients aged 19 or older
- •Patients with knee joint pain due to chondromalacia, osteoarthritis (OA), or traumatic arthritis (TA)
- •Patients with 3 or lower score in the Kellgren-Lawrence grade
- •Patients with 40 mm or higher scores in the 100 mm VAS pain scale
- •Patients without significant pathological tests at their screening visit
- •Patients whose medication is confirmed within one week from their study enrolment and who agreed to maintain the medication dose during the study period if they need to keep taking it
- •When combination drugs are administered, considering the period of the drugs remaining in the body, patients who take the drugs stably for 2 weeks prior to participating in the trial (based on the screening, if it is confirmed that the patients took the drugs stably for 1 week prior to the screening, at the enrollment for injection, it should be assessed again, and the patients who are confirmed to have taken the drugs stably for 2 weeks prior to the trial could be registered).
- •Patients who, after taking drugs for anesthetic purposes (provided to the subject after the injection) within one week after the intra-articular injection, agreed to take anti-inflammatory agents for no more than 5 consecutive days and for no more than 10 days in a month, and could stop taking the drugs within 2 days after the next visit even if the pain in the observation site becomes severe and thus additional drugs are required.
- •Patients who agreed to use only the non-drug treatments (i.e., physiotherapy, osteopathy, and chiropractic therapy) allowed by the study investigators (Acupuncture is not allowed.)
- •Patients who agreed to receive the injection only in one knee when they feel pain on both knees (The other knee can be treated with prescribed drugs, but articular injections are not allowed.)
- •Patients or their representative (for adults) who agreed to participate in the study and signed the informed consent form
排除标准
- •Patients or their family members with a history of or an ongoing autoimmune disease
- •Patients with a history of anaphylactic response
- •Patients with hypersensitivity to grafting materials
- •Patients with hypersensitivity to porcine protein
- •Patient with grade 4 in the Kellgren-Lawrence grade
- •Patients with severe effusion
- •Patients who were injured severely or received injection in their affected knee within six months, which would make evaluation of the knee difficult
- •Patients with inflammatory arthritis such as rheumatoid arthritis, rupus arthrosis, or psoriatic arthritis
- •Patients who have gout or calcium pyrophosphate (pseudogout) disease that started within six months from the screening visit
- •Patients with a history of radiation therapy or cancer treatment within two years
- •Patients with diabetes
- •Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
- •Patients who have been undergoing adrenocortical hormone therapy
- •Patients with liver, heart, or kidney disease
- •Patients who had been infected with a virus
- •Patients who have a serious health condition that may affect the study results
- •Patients who are pregnant, breastfeeding, or planning to become pregnant
- •Patients who are considered inappropriate for participation in this study due to their condition (e.g., a mental illness) based on the investigator's judgment
- •8-15: The investigator can decide whether or not the patient will be administered the injection.
研究组 & 干预措施
CartiZol, collagen injection
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)
Normal Saline injection
Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.
干预措施: Normal saline (Drug)
结局指标
主要结局
Score change of 100 mm VAS
时间窗: 24 weeks after injection
The difference of the score of the investigational group and the control group at baseline and 24 weeks after injection will be calculated and analyzed
100 mm Visual Analogue Score (VAS)
时间窗: 24 weeks after injection
100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at 24 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain.
次要结局
- Score change of SF-36 (36-ltem Short-Form Health Survey)(at the screening visit and then 4, 12, and 24 weeks after injection)
- Score change of Physical examination(at the screening visit and then 4, 12, and 24 weeks after injection)
- Score change of Satisfaction evaluation by physician in charge(at 4, 12, and 24 weeks after injection)
- Score change of WOMAC (Western Ontario and McMaster Universities)(at the screening visit and then 4, 12, and 24 weeks after injection)
- Score change of Satisfaction evaluation by patients(at 4, 12, and 24 weeks after injection)
- Score change of 100 mm VAS(at the screening visit and then 4 and 12weeks after injection)
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )(at the screening visit, 4, 12, and 24 weeks after injection)
- 36-ltem Short-Form Health Survey (SF-36)(at the screening visit, 4, 12, and 24 weeks after injection)
- Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation(at 4, 12, and 24 weeks after injection)
- Number of Patients With Satisfying Improvement Assessed by Physicians(at 4, 12, and 24 weeks after injection)
- Physical Examination(at the screening visit, 4, 12, and 24 weeks after injection)
- 100 mm VAS(at the screening visit, 4 and 12 weeks after injection)