NCT07511777

Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hyaluronic Acid on Knee Osteoarthritis

A Double Blind, Randomized Post Marketing Clinical Trial to Assess the Safety and Efficacy of Intra-articular Injection Collagen Versus Hyaluronic Acid on Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cellontech Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthitis

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.
DRUG	Synovian 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.

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-08-05
• Completion: 2025-11-13
• First posted: 2026-04-06
• Last updated: 2026-04-13

Locations

1 site across 1 country: South Korea