Efficacy of intra-articular collagen injection in patients with knee joint pain compared to normal saline injection

INTERVENTION: Masking of the treatments was done by concealing the contents of the syringe when it was administered to the patients. Allocation of the patient into experimental group and control group was done by computational system prepared by the specialist. 1. Experimental group: Patients receive intra‐articular injection of CartiZol (type I atelocollagen). Dose of administration was 3 ml, and it was administered at the beginning of the trial for one time. 2. Control group: Patients receive intra‐articular injection of saline. Dose of adminstration was 3 ml, and it was administered at the beginning of the trial for one time. Participants are asked to meet the physicians at 4, 12, and 24 weeks for their clinical evaluation. CONDITION: Chondromalacia, osteoarthritis, traumatic arthritis ; Musculoskeletal Diseases PRIMARY OUTCOME: Pain in the knee joint is measured using the 100mm visual analogue score (VAS) at 24 weeks after injection SECONDARY OUTCOME: ; 1. Pain, stiffness, and physical function of the knee joint are measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at baseline, 4 weeks, 12 weeks, and 24 weeks; 2. Quality of life is measured using the 36‐ltem Short‐Form Health Survey (SF‐36) at baseline, 4 weeks, 12 weeks, and 24 weeks; 3. Satisfaction level with improvement of the knee measured by patient self‐evaluation at 4 weeks, 12 weeks, and 24 weeks; 4. Satisfaction level with improvement of the patient’s knee measured by physician evaluation at 4 weeks, 12 weeks, and 24 weeks; 5. Patients’ physical condition under 24 pre‐specified categories assessed by physical examination at baseline, 4 weeks, 12 weeks, and 24 weeks; 6. Pain on the knee joint measured using the 100mm visual analogue score (VAS) at baseline, 4 weeks, and 12 weeks; INCLUSION CRITERIA: 1. Adult patients aged 19 or older 2. Patients with knee joint pain due to chondromalacia, osteoarthritis (OA), or traumatic arthritis (TA) 3. Patients with 3 or lower score in the Kellgren‐Lawrence grade 4. Patients with 40 mm or higher scores in the 100 mm VAS pain scale 5. Patients without significant pathological tests at their screening visit 6. 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 7. 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 t