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Knee pain relief without surgery? collagen injection shows promise

NCT ID NCT02539095

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether injecting a collagen product called CartiZol into the knee can reduce pain in people with osteoarthritis, cartilage damage, or injury-related arthritis. 200 adults with knee pain received either the collagen injection or a placebo (saline). The main goal was to measure pain levels 24 weeks after the injection using a standard pain scale. The trial is complete, and results may show whether this simple injection offers a new way to manage knee pain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CartiZol (absorbable collagen injection)
What this could lead to
If it works, this could offer a simple injection to ease knee pain from arthritis or injury, potentially delaying or avoiding surgery.
What could go wrong
This is a single completed Phase 4 trial with 200 participants. The effect may be modest, and not everyone may benefit. Long-term safety and effectiveness are not yet fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

200 people

The number who actually took part.

Start date

Apr 2014

Finished

Aug 2015

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Chung-Ang University Hospital

    Seoul, South Korea

  • Kunkuk University Medical Center

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

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

    Seoul, South Korea

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

    Seoul, South Korea

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