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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
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.
A hyaluronic acid gel-type intra-articular injection, Synovian inj., facilitates joint lubrication and helps protect cartilage, thereby alleviating pain associated with knee osteoarthritis.
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Visual Analogue Scale (VAS) for Pain (0-100 mm)
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)
Time frame: From screening to 12, 24, and 52 weeks post-injection
Visual Analogue Scale (VAS) for Pain (0-100 mm)
1. Efficacy Evaluation Analysis The change in the VAS score of the affected knee between screening and 4 weeks post-injection will be compared between the test group and the control group. The VAS score of the affected knee at 4 weeks post-injection will be compared between the test group and the control group. The intra-group change in the VAS score of the affected knee between screening and 4 weeks post-injection will be compared for each 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)
Time frame: From screening to 4, 12, 24, and 52 weeks post-injection
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
1. Efficacy Evaluation Analysis The change in the WOMAC score of the affected knee between screening and 4 and 12 weeks post-injection will be compared between the test group and the control group. The WOMAC score of the affected knee at 4 and 12 weeks post-injection will be compared between the test group and the control group. The intra-group change in the WOMAC score of the affected knee between screening and 4 and 12 weeks post-injection will be compared for each 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 range: 0-96 (higher scores indicate worse pain, stiffness, and physical dysfunction)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From screening to 4, 12, 24, and 52 weeks post-injection
Short Form-36 Health Survey (SF-36)
1. Efficacy Evaluation Analysis The change in the SF-36 score of the affected knee between screening and 4 and 12 weeks post-injection will be compared between the test group and the control group. The SF-36 score of the affected knee at 4 and 12 weeks post-injection will be compared between the test group and the control group. The intra-group change in the SF-36 score of the affected knee between screening and 4 and 12 weeks post-injection will be compared for each 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 range: 0-100 (higher scores indicate better health-related quality of life)
Time frame: From screening to 4, 12, 24, and 52 weeks post-injection
Participant satisfaction
1. Efficacy Evaluation Analysis The score of the affected knee at 4 and 12 weeks post-injection will be compared between the test group and the control group. 2. Safety Evaluation Analysis The evaluation values at 24 and 52 weeks post-injection will be compared between the test group and the control group. Scale description: Participants rated their overall satisfaction regarding pain relief and functional improvement compared to pre-injection status using a 5-point scale: 4 = Markedly improved 3 = Slightly improved 2 = No change 1 = Slightly worsened 0 = Markedly worsened (higher scores indicate greater improvement)
Time frame: At 4, 12, 24, and 52 weeks post-injection
Investigator satisfaction
1. Efficacy Evaluation Analysis The score of the affected knee at 4 and 12 weeks post-injection will be compared between the test group and the control group. 2. Safety Evaluation Analysis The evaluation values at 24 and 52 weeks post-injection will be compared between the test group and the control group. Investigators rated the overall improvement in pain and functional status of the affected knee compared to the pre-injection condition using a 5-point scale: 4 = Markedly improved 3 = Slightly improved 2 = No change 1 = Slightly worsened 0 = Markedly worsened compared to pre-injection (higher scores indicate greater improvement)
Time frame: At 4, 12, 24, and 52 weeks post-injection
X-ray examination (Kellgren-Lawrence Grade 1-4)
1. Efficacy Evaluation Analysis The score of the affected knee at 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: Grade 1-4 (higher grades indicate more severe osteoarthritis)
Time frame: At 12, 24, and 52 weeks post-injection
Biomarker test
1. Efficacy Evaluation Analysis The change in the test values between screening and 12 weeks post-injection will be compared between the test group and the control group. The test values at 12 weeks post-injection will be compared between the test group and the control group. 2. Follow-up Evaluation Analysis The changes from baseline 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: Continuous laboratory values (units vary by parameter; higher values may indicate abnormal findings depending on the parameter) Parameters include hematologic and serum biochemical tests such as WBC, RBC, hemoglobin(Hb), hematocrit(Hct), platelets(PLT), differential counts, erythrocyte sedimentation rate(ESR), blood urea nitrogen(BUN), creatinine, C-reactive protein(CRP), aspartate aminotransferase(AST), and alanine aminotransferase(ALT).
Time frame: From screening to 12, 24, and 52 weeks post-injection, and at 12, 24, and 52 weeks post-injection