Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hya… (NCT07511777) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hyaluronic Acid on Knee Osteoarthritis
South Korea100 participantsStarted 2024-02-06
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. Patients with ongoing or past autoimmune diseases, either personally or in their family
What they're measuring
1
Visual Analogue Scale (VAS) for Pain (0-100 mm)
Timeframe: From screening to 12, 24, and 52 weeks post-injection
. 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)