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Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage

NCT07267793 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-01-20

No results posted yet for this study

Summary

This clinical trial aims to evaluate and compare the efficacy and safety of CartiPRO, an approved intra-articular atelocollagen injection, versus Synovian injection for the relief of knee pain in patients with knee osteoarthritis. The investigational device is administered intra-articularly, with a second injection given 24 weeks after the first dose. Primary and secondary endpoints include changes in pain scores (VAS), functional assessments (WOMAC, SF-36), and safety evaluations over a 36-week period.

Conditions

  • Osteoarthritis
  • Knee Pain Arthritis
  • Cartilage Defects of the Knee
  • Knee Osteoarthritis
  • Degenerative Joint Disease of Knee

Interventions

DEVICE

CartiPRO

Clinical subjects are enrolled after the investigator confirms eligibility, and subjects in the study group receive treatment Dalim Tissen's CartiPRO. Intra-articular medical device injection at baseline and Week 12; final assessment at Week 36.

DRUG

Synovian®

Clinical subjects are enrolled after the investigator confirms eligibility, and subjects in the study group receive treatment Synovian®. Intra-articular medical device injection at baseline and Week 12; final assessment at Week 36.

Sponsors & Collaborators

  • DALIM TISSEN Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yong In, Ph.D · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-03
Primary Completion
2026-02-28
Completion
2026-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07267793 on ClinicalTrials.gov