Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Norma… (NCT02539095) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection
South Korea200 participantsStarted 2014-04
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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