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

NCT02539095 | Completed Phase 4 Results DMC

• 1 other identifier: 01CTZ
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chondromalacia; Osteoarthritis; Traumatic Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 100 mm Visual Analogue Score (VAS)

  100 mm Visual Analogue Score (VAS) is measurement instrument for subjective characteristics or attitudes that cannot be directly measured. In this trial, it is used for quantification of the pain on the defected knee. The VAS score of the investigational group and the control group at 24 weeks after injection will be compared and analyzed. Score range: 0 \~ 100 mm Higher score indicates the worse outcome. In this case, participant is feeling more pain.

  24 weeks after injection

Secondary Outcomes (6)

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )

  at the screening visit, 4, 12, and 24 weeks after injection

• 36-ltem Short-Form Health Survey (SF-36)

  at the screening visit, 4, 12, and 24 weeks after injection

• Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation

  at 4, 12, and 24 weeks after injection

• Number of Patients With Satisfying Improvement Assessed by Physicians

  at 4, 12, and 24 weeks after injection

• Physical Examination

  at the screening visit, 4, 12, and 24 weeks after injection

Study Arms (2)

CartiZol, collagen injection

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

Normal Saline injection

PLACEBO COMPARATOR

Their eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table.

Drug: Normal saline

Interventions

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. Place the needle on the tip of the syringe and inject the product into the articular cavity.

Also known as: Intra articular collagen injection

CartiZol, collagen injection

Normal saline DRUG

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.

Also known as: placebo

Normal Saline injection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 19 or older
• Patients with knee joint pain due to chondromalacia, osteoarthritis (OA), or traumatic arthritis (TA)
• Patients with 3 or lower score in the Kellgren-Lawrence grade
• Patients with 40 mm or higher scores in the 100 mm VAS pain scale
• Patients without significant pathological tests at their screening visit
• 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
• 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 the enrollment for injection, it should be assessed again, and the patients who are confirmed to have taken the drugs stably for 2 weeks prior to the trial could be registered).
• Patients who, after taking drugs for anesthetic purposes (provided to the subject after the injection) within one week after the intra-articular injection, agreed to take anti-inflammatory agents for no more than 5 consecutive days and for no more than 10 days in a month, and could stop taking the drugs within 2 days after the next visit even if the pain in the observation site becomes severe and thus additional drugs are required.
• Patients who agreed to use only the non-drug treatments (i.e., physiotherapy, osteopathy, and chiropractic therapy) allowed by the study investigators (Acupuncture is not allowed.)
• Patients who agreed to receive the injection only in one knee when they feel pain on both knees (The other knee can be treated with prescribed drugs, but articular injections are not allowed.)
• Patients or their representative (for adults) who agreed to participate in the study and signed the informed consent form

You may not qualify if:

• Patients or their family members with a history of or an ongoing autoimmune disease
• Patients with a history of anaphylactic response
• Patients with hypersensitivity to grafting materials
• Patients with hypersensitivity to porcine protein
• Patient with grade 4 in the Kellgren-Lawrence grade
• Patients with severe effusion
• Patients who were injured severely or received injection in their affected knee within six months, which would make evaluation of the knee difficult
• Patients with inflammatory arthritis such as rheumatoid arthritis, rupus arthrosis, or psoriatic arthritis
• Patients who have gout or calcium pyrophosphate (pseudogout) disease that started within six months from the screening visit
• Patients with a history of radiation therapy or cancer treatment within two years
• Patients with diabetes
• Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents
• Patients who have been undergoing adrenocortical hormone therapy
• Patients with liver, heart, or kidney disease
• Patients who had been infected with a virus

Sponsors & Collaborators

• Cellontech Co., Ltd.: lead

Study Sites (5)

Chung-Ang University Hospital

Seoul, South Korea

Location

Kunkuk University Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

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

Seoul, South Korea

Location

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Cartilage Diseases; Osteoarthritis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinial research manager
• Organization: Sewon Cellontech Co., Ltd.

angel@swcell.com

Study Officials

• Young Wan Moon, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Yong In, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Han Jun Lee, MD

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

• Kwang Jun Oh, MD

  Kunkuk University Medical Center

  PRINCIPAL INVESTIGATOR

• Hwa Sung Lee, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: April 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2018-08

Locations

KR (5)