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

NCT07511777 | Completed

• 1 other identifier: 02CTZ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthitis

Keywords

intra-articular injection; intra-articular collagen injection; collagen; knee joint pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) for Pain (0-100 mm)

  1. Efficacy Evaluation Analysis The change in the VAS score of the affected knee between screening and 12 weeks post-injection will be compared between the test group and the control group. 2. Follow-up Evaluation Analysis The changes from baseline (screening) to 24 and 52 weeks post-injection, the values at 24 and 52 weeks post-injection, and the intra-group changes at 24 and 52 weeks post-injection will be compared between the test and control groups. Scale description: 0 = no pain, 100 = worst imaginable pain (higher scores indicate worse pain)

  From screening to 12, 24, and 52 weeks post-injection

Secondary Outcomes (7)

• Visual Analogue Scale (VAS) for Pain (0-100 mm)

  From screening to 4, 12, 24, and 52 weeks post-injection

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  From screening to 4, 12, 24, and 52 weeks post-injection

• Short Form-36 Health Survey (SF-36)

  From screening to 4, 12, 24, and 52 weeks post-injection

• Participant satisfaction

  At 4, 12, 24, and 52 weeks post-injection

• Investigator satisfaction

  At 4, 12, 24, and 52 weeks post-injection

Study Arms (2)

CartiZol

EXPERIMENTAL

Their eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table.

Device: CartiZol

Synovian inj. (Hyaluronic acid)

ACTIVE COMPARATOR

Their eligibility to participate in the study is checked, and they are randomized into the intra-articular hyaluronic acid injection group based on a randomization table.

Drug: Synovian inj.

Interventions

Synovian inj. DRUG

A hyaluronic acid gel-type intra-articular injection, Synovian inj., facilitates joint lubrication and helps protect cartilage, thereby alleviating pain associated with knee osteoarthritis.

Also known as: Intra-articular hyaluronic acid injection

Synovian inj. (Hyaluronic acid)

CartiZol DEVICE

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.

Also known as: Intra-articular collagen injection

CartiZol

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 years or older
• Patients with knee pain due to osteoarthritis (OA)
• Patients with Kellgren-Lawrence grade 3 or less
• Patients with a 100 mm VAS pain level of 40 mm or greater
• Patients without clinically significant clinical pathology test results during the screening period
• Patients who confirmed accurate prescription records for medications taken within at least one week before the study and agree to maintain the same dosage of concomitant medications as before the injection if such medications are continuously administered during the study period
• If taking concomitant medications, patients who have been on stable medication for approximately two weeks before participating in the study, considering the duration of drug maintenance in the body (stability must be confirmed one week before screening and reconfirmed at the time of registration when the injection is applied to ensure two weeks of stable medication use)
• Rescue analgesic medications administered within one week of intra-articular injection are allowed (given to the subject after injection), provided that if additional analgesics are required due to increased pain at the observation site, patients should agree not to use more than 5 consecutive days or 10 days per month, and to stop taking analgesics at least 2 days before the next visit.
• Patients who agree to undergo only non-drug therapies (physical therapy, osteopathy, chiropractic care) as allowed by a clinician (excluding acupuncture)
• Patients who agree to have the injection administered to the more painful knee if both knees are affected (intra-articular injections in the contralateral knee are prohibited)
• Patients or their legal representatives who consent to participate in the study and sign the written informed consent form

You may not qualify if:

• Patients with ongoing or past autoimmune diseases, either personally or in their family
• Patients with a history of anaphylactic reactions
• Patients with hypersensitivity to implants
• Patients with hypersensitivity to porcine protein
• Patients with a Kellgren-Lawrence grade of 4
• Patients with severe effusion
• Patients who had a serious injury or received an injection in the affected knee that may interfere with evaluation within 6 months prior to screening
• Patients with inflammatory arthritis, such as rheumatoid arthritis, lupus arthritis, or psoriatic arthritis (except when deemed eligible for collagen administration by the clinician)
• Patients with gout or pseudogout diagnosed within 6 months prior to screening (except when deemed eligible for collagen administration by the clinician)
• Patients with a history of radiation or chemotherapy within the past 2 years (except when deemed eligible for collagen administration by the clinician)
• Diabetic patients (except those who maintain normal blood sugar levels, have no complications related to diabetes, and are deemed eligible for collagen administration by the clinician)
• Patients with infections receiving treatment with antibiotics or antimicrobials that require hospitalization (except when deemed eligible for collagen administration by the clinician)
• Patients receiving adrenocortical hormone therapy (except when deemed eligible for collagen administration by the clinician)
• Patients with heart, liver, or kidney diseases (except those maintaining normal test results or deemed clinically insignificant by the clinician, in which case collagen administration is allowed; hypertension excluded)
• Patients with viral infections (except those maintaining normal test results or deemed clinically insignificant by the clinician, in which case collagen administration is allowed)

Sponsors & Collaborators

• Cellontech Co., Ltd.: lead

Study Sites (1)

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Yong In, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Man-Soo Kim, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Geun-Yooung Choi, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: February 6, 2024
• Primary Completion: August 5, 2025
• Study Completion: November 13, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

KR (1)