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.
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.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
1. Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2. Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
Chung-Ang University Hospital
Seoul, South Korea
Kunkuk University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
100 mm Visual Analogue Score (VAS)
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.
Time frame: 24 weeks after injection
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standarized questionnaires to evaluate the condition of patients with osteoarthritis. The WOMAC score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 Higher score indicates the worse outcome.
Time frame: at the screening visit, 4, 12, and 24 weeks after injection
36-ltem Short-Form Health Survey (SF-36)
36-ltem Short-Form Health Survey (SF-36) is a patient-reported survey of patient health to determine the cost-effectiveness of a health treatment. The SF-36 score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 Higher score indicates a better outcome.
Time frame: at the screening visit, 4, 12, and 24 weeks after injection
Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation
The improvement level of the investigational group and the control group will be evaluated by patients at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed.
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The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, South Korea
Time frame: at 4, 12, and 24 weeks after injection
Number of Patients With Satisfying Improvement Assessed by Physicians
The improvement level of the investigational group and the control group will be evaluated by clinicians at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed.
Time frame: at 4, 12, and 24 weeks after injection
Physical Examination
Physical examination was performed by the investigator at each visit (baseline, 4 weeks, 12 weeks, and 24 weeks). Selected key parameters were evaluated and categorized by severity. Each participant was assigned to a single category for each parameter at each time point, and the number of participants in each category was summarized for each arm/group. ※ Category titles are presented as: "Examination item (e.g., AP alignment)" - "Condition (e.g., varus or valgus)".
Time frame: at the screening visit, 4, 12, and 24 weeks after injection
100 mm VAS
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 baseline, 4 weeks and 12 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.
Time frame: at the screening visit, 4 and 12 weeks after injection