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

NCT ID: NCT02539095

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-12-31

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.

Detailed Description

This study is a double-blind 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cartizol, collagen injection

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

Group Type: EXPERIMENTAL

CartiZol

Intervention Type: 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.

Normal Saline injection

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Intra articular collagen injection; placebo

Eligibility Criteria

Inclusion Criteria

• 1. Adult patients aged 19 or older 2. Patients with knee joint pain due to chondromalacia, osteoarthritis (OA), or traumatic arthritis (TA) 3. Patients with 3 or lower score in the Kellgren-Lawrence grade 4. Patients with 40 mm or higher scores in the 100 mm VAS pain scale 5. Patients without significant pathological tests at their screening visit 6. 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 7. 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).

8. 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.

9. 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.) 10. 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.) 11. Patients or their representative (for adults) who agreed to participate in the study and signed the informed consent form

Exclusion Criteria

• 1. Patients or their family members with a history of or an ongoing autoimmune disease 2. Patients with a history of anaphylactic response 3. Patients with hypersensitivity to grafting materials 4. Patients with hypersensitivity to porcine protein 5. Patient with grade 4 in the Kellgren-Lawrence grade 6. Patients with severe effusion 7. Patients who were injured severely or received injection in their affected knee within six months, which would make evaluation of the knee difficult 8. Patients with inflammatory arthritis such as rheumatoid arthritis, rupus arthrosis, or psoriatic arthritis 9. Patients who have gout or calcium pyrophosphate (pseudogout) disease that started within six months from the screening visit 10. Patients with a history of radiation therapy or cancer treatment within two years 11. Patients with diabetes 12. Patients with an infection that required hospitalization for antibiotics or the administration of antiseptic agents 13. Patients who have been undergoing adrenocortical hormone therapy 14. Patients with liver, heart, or kidney disease 15. Patients who had been infected with a virus 16. Patients who have a serious health condition that may affect the study results 17. Patients who are pregnant, breastfeeding, or planning to become pregnant 18. Patients who are considered inappropriate for participation in this study due to their condition (e.g., a mental illness) based on the investigator's judgment 8-15: The investigator can decide whether or not the patient will be administered the injection.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sewon Cellontech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young Wan Moon, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Cente

Yong In, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Han Jun Lee, MD

Role: PRINCIPAL_INVESTIGATOR

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

Kwang Jun Oh, MD

Role: PRINCIPAL_INVESTIGATOR

Kunkuk University Medical Center

Hwa Sung Lee, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Yeouido St. Mary's Hospital

Locations

Chung-Ang University Hospital

Seoul, Seoul, South Korea

Kunkuk University Medical Center

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

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

Seoul, Seoul, South Korea

The Catholic University of Yeouido St. Mary's Hospital

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

01CTZ

Identifier Type: -

Identifier Source: org_study_id