NCT02539095

Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection

Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-blind, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Cellontech Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is a double-blind, randomized clinical trial. Two hundred subjects has participated in it. The study is explained to the subjects, and they voluntarily choose to participate in it. Their eligibility to participate in the study is checked, and they are randomized either into the intra-articular collagen injection group or the normal saline (placebo) injection group based on a randomization table. They are asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects will undergo an examination with doctors, a medical examination by interview, and a blood test only when it is necessary to evaluate the safety and efficacy of the injection. (\*If the subjects performed the screening during the first visit on, the total number of his or her additional visits is four.)

Conditions

• Chondromalacia
• Osteoarthritis
• Traumatic Arthritis

Interventions

Type	Name	Description
DEVICE	CartiZol	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. Place the needle on the tip of the syringe and inject the product into the articular cavity.
DRUG	Normal saline	1. Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2. Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-09-02
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

5 sites across 1 country: South Korea