Osteoarthitis
Conditions
Keywords
intra-articular injection, intra-articular collagen injection, collagen, knee joint pain
Brief summary
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.
Detailed description
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.
Interventions
DRUGSynovian inj.
A hyaluronic acid gel-type intra-articular injection, Synovian inj., facilitates joint lubrication and helps protect cartilage, thereby alleviating pain associated with knee osteoarthritis.
DEVICECartiZol
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.
Sponsors
Cellontech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults aged 19 years or older 2. Patients with knee pain due to osteoarthritis (OA) 3. Patients with Kellgren-Lawrence grade 3 or less 4. Patients with a 100 mm VAS pain level of 40 mm or greater 5. Patients without clinically significant clinical pathology test results during the screening period 6. 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 7. 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) 8. 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. 9. Patients who agree to undergo only non-drug therapies (physical therapy, osteopathy, chiropractic care) as allowed by a clinician (excluding acupuncture) 10. 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) 11. Patients or their legal representatives who consent to participate in the study and sign the written informed consent form
Exclusion criteria
1. Patients with ongoing or past autoimmune diseases, either personally or in their family 2. Patients with a history of anaphylactic reactions 3. Patients with hypersensitivity to implants 4. Patients with hypersensitivity to porcine protein 5. Patients with a Kellgren-Lawrence grade of 4 6. Patients with severe effusion 7. 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 8. Patients with inflammatory arthritis, such as rheumatoid arthritis, lupus arthritis, or psoriatic arthritis (except when deemed eligible for collagen administration by the clinician) 9. Patients with gout or pseudogout diagnosed within 6 months prior to screening (except when deemed eligible for collagen administration by the clinician) 10. Patients with a history of radiation or chemotherapy within the past 2 years (except when deemed eligible for collagen administration by the clinician) 11. 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) 12. Patients with infections receiving treatment with antibiotics or antimicrobials that require hospitalization (except when deemed eligible for collagen administration by the clinician) 13. Patients receiving adrenocortical hormone therapy (except when deemed eligible for collagen administration by the clinician) 14. 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) 15. Patients with viral infections (except those maintaining normal test results or deemed clinically insignificant by the clinician, in which case collagen administration is allowed) 16. Patients with any clinically significant medical condition that may affect the completion of the study 17. Patients who are pregnant, breastfeeding, or planning to become pregnant 18. Patients with mental illness or others deemed inappropriate for the study by the study staff 19. Patients scheduled for surgery during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for Pain (0-100 mm) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) for Pain (0-100 mm) | From screening to 4, 12, 24, and 52 weeks post-injection | 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) |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) | From screening to 4, 12, 24, and 52 weeks post-injection | 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) |
| Short Form-36 Health Survey (SF-36) | From screening to 4, 12, 24, and 52 weeks post-injection | 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) |
| Participant satisfaction | At 4, 12, 24, and 52 weeks post-injection | 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) |
| Investigator satisfaction | At 4, 12, 24, and 52 weeks post-injection | 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) |
| X-ray examination (Kellgren-Lawrence Grade 1-4) | At 12, 24, and 52 weeks post-injection | 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) |
| Biomarker test | From screening to 12, 24, and 52 weeks post-injection, and at 12, 24, and 52 weeks post-injection | 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). |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORYong In, MD
The Catholic University of Korea
PRINCIPAL_INVESTIGATORMan-Soo Kim, MD
The Catholic University of Korea
PRINCIPAL_INVESTIGATORGeun-Yooung Choi, MD
The Catholic University of Korea
Outcome results
None listed