ChondromalaciaPhase 4NCT02539095
Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection
A Phase 4 study testing CartiZol and Normal saline in people with Chondromalacia and Osteoarthritis, run by Cellontech Co., Ltd. at 5 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chondromalacia, Osteoarthritis, Traumatic Arthritis
- What is being tested?
- CartiZol and Normal saline
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Apr 2014to Aug 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Patients who have a serious health condition that may affect the study results
- Patients who are pregnant, breastfeeding, or planning to become pregnant
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Chung-Ang University Hospital
Seoul
Kunkuk University Medical Center
Seoul
Samsung Medical Center
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
About this study
Official title: Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-blind, Randomized Controlled Trial
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.
Read the detailed description
This study is a double-blind, randomized 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
- Being tested
- CartiZol, Normal saline
- Keywords
- intra-articular injection, intra-articular collagen injection, collagen, knee joint pain
- Medical subject headings
- Cartilage Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartiZolDevice
Also called Intra articular collagen injection
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 salineDrug
Also called placebo
- Supplementation of fluid and electrolytes (sodium or chlorine deficiency)
- Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks after injection
Secondary outcomes (6)
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a set of standarized questionnaires to evaluate the condition of patients with osteoarthritis. The WOMAC score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed.
Score range: 0 ~ 100 Higher score indicates the worse outcome.
Measured: at the screening visit, 4, 12, and 24 weeks after injection
36-ltem Short-Form Health Survey (SF-36)
36-ltem Short-Form Health Survey (SF-36) is a patient-reported survey of patient health to determine the cost-effectiveness of a health treatment. The SF-36 score of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be compared and analyzed.
Score range: 0 ~ 100 Higher score indicates a better outcome.
Measured: at the screening visit, 4, 12, and 24 weeks after injection
Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation
The improvement level of the investigational group and the control group will be evaluated by patients at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed.
Measured: at 4, 12, and 24 weeks after injection
Number of Patients With Satisfying Improvement Assessed by Physicians
The improvement level of the investigational group and the control group will be evaluated by clinicians at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed.
Measured: at 4, 12, and 24 weeks after injection
Physical Examination
Physical examination was performed by the investigator at each visit (baseline, 4 weeks, 12 weeks, and 24 weeks). Selected key parameters were evaluated and categorized by severity. Each participant was assigned to a single category for each parameter at each time point, and the number of participants in each category was summarized for each arm/group.
※ Category titles are presented as: "Examination item (e.g., AP alignment)" - "Condition (e.g., varus or valgus)".
Measured: at the screening visit, 4, 12, and 24 weeks after injection
100 mm 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 baseline, 4 weeks and 12 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.
Measured: at the screening visit, 4 and 12 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ChondromalaciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellontech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young Wan Moon, MD, Principal investigator, Samsung Medical CenterYong In, MD, Principal investigator, The Catholic University of KoreaHan Jun Lee, MD, Principal investigator, Chung-Ang University HospitalKwang Jun Oh, MD, Principal investigator, Kunkuk University Medical CenterHwa Sung Lee, MD, Principal investigator, The Catholic University of Korea, Yeouido St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539095
- Sponsor's protocol ID
- 01CTZ
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2015
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Injection of Type I Atelocollagen to Alleviate Knee Pain: A Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02539095
- Acronym / sponsor ID
- 01CTZ
- Conditions
- Chondromalacia, Osteoarthritis, Traumatic Arthritis
- Keywords
- intra-articular injection, intra-articular collagen injection, collagen, knee joint pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cellontech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Posted 17 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, randomized 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.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CartiZol, collagen injection | Experimental | Device: CartiZolTheir eligibility to participate in the study is checked, and they are randomized into the intra-articular collagen injection group based on a randomization table. |
| Normal Saline injection | Placebo comparator | Drug: Normal salineTheir eligibility to participate in the study is checked, and they are randomized into the (placebo) injection group based on a randomization table. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CartiZolAlso: Intra articular collagen injectionThe 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. | Device | CartiZol, collagen injection |
| Normal salineAlso: placebo1. 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. | Drug | Normal Saline injection |
Primary outcome
100 mm Visual Analogue Score (VAS)
Time frame: 24 weeks after injection
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.
6 secondary outcomes
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index )
Time frame: at the screening visit, 4, 12, and 24 weeks after injection
36-ltem Short-Form Health Survey (SF-36)
Time frame: at the screening visit, 4, 12, and 24 weeks after injection
Number of Patients Who Are Satisfied With Improvement Assessed by Self-evaluation
Time frame: at 4, 12, and 24 weeks after injection
Number of Patients With Satisfying Improvement Assessed by Physicians
Time frame: at 4, 12, and 24 weeks after injection
Physical Examination
Time frame: at the screening visit, 4, 12, and 24 weeks after injection
100 mm VAS
Time frame: at the screening visit, 4 and 12 weeks after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Wan Moon, MD principal investigator
Samsung Medical Center
Yong In, MD principal investigator
The Catholic University of Korea
Han Jun Lee, MD principal investigator
Chung-Ang University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CartiZol and Normal saline in people with Chondromalacia and Osteoarthritis, run by Cellontech Co., Ltd. at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100 mm Visual Analogue Score (VAS) (time frame: 24 weeks after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.