OsteoarthritisCartiSaveNCT07907926
Clinical Trial of Type II Collagen vs. Sodium Hyaluronate Intra-articular Injection in Knee Osteoarthritis
A study testing CartiSave and Hyalforte Injection in people with Osteoarthritis and Osteoarthritis Knee Pain, run by ATEMs at 4 sites in South Korea.
Trial summary
The purpose of this clinical trial is to evaluate the efficacy and safety of CartiSave compared with sodium hyaluronate in patients with knee pain. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Osteoarthritis, Osteoarthritis Knee Pain, Knee Arthritis
- What is being tested?
- CartiSave and Hyalforte Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 27 Oct 2025to 9 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adults aged 19 years or older
- 2. Patients who agreed to participate in the study and signed the informed consent form
- 3. Patients whose target knee joint intended for investigational product injection meet all of the following conditions at the screening visit:
- 1) Knee joint pain due to Osteoarthritis
- 2) Kellgren-Lawrence (K-L) Grade I to III confirmed by X-ray examination
- 3) 100 mm Visual Analogue Scale (VAS) pain score of 40mm or higher during activity
- 4) Absence of significant pathological findings, such as tumors
- 4. Patients who agree to use medically acceptable methods of contraception throughout the clinical trial period
Who cannot join
- 1. Patients with a known hypersensitivity or history of allergic reactions to the active substance or any components of the investigational medical device or comparator drug (e.g., porcrine-derived proteins)
- 2. Patients or their family members with autoimmune diseases
- 3. Patients with inflammatory arthritis such as rheumatoid arthritis, lupus arthritis, or psoriatic arthritis
- 4. Patients with any of the following medical history or conditions at the screening visit:
- 1) History of radiation therapy or cancer treatment within 2 years
- 2) Severe knee trauma, surgery, or injection in the knee within 6 months that makes knee evaluation difficult
Show all 19Show fewer
- 3) Gout or calcium pyrophosphate deposition disease with onset within 6 months
- 4) Severe intra-articular effusion
- 5) Infectious disease requiring hospitalization for the administration of antibiotics
- 6) Clinically significant, medically uncontrolled disease that may interfere with the study (e.g., hepatic, cardiac, renal, oncologic, diabetic, or psyshiatric disorders)
- 5. Patients who use corticosteroids as follows at the screening visit:
- 1) intra-articular injection at the target knee within 3 months
- 2) systemic drug use within 3 months
- 3) intra-articular injection at a joint other than the target knee within 4 weeks
- 4) topical use is permitted except the target knee
- 6. Patients who have received analgesics or anti-inflammatory drugs within 48 hours prior to the screening visit
- 7. Patients who are pregnant, breastfeeding, or planning to become pregnant during the trial
- 8. Patients who have participated in other interventional studies within 30 days prior to the screening visit
- 9. Patients who are considered inappropriate for participation in this study based on the investigator's judgement
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Dongguk University Ilsan Hospital
Gyeonggi-do, Goyang-si, 10326
Cha University Bundang Medical Center
Gyeonggi-do, Seongnam, 13496
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Hallym University Kangnam Sacred Heart Hospital
Seoul, Yeongdeungpo-gu, 07441
About this study
Official title: A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Clinical Trial to Evaluate the Efficacy and Safety of 'CartiSave' in Patients With Knee Joint Pain
The purpose of this clinical trial is to evaluate the efficacy and safety of CartiSave compared with sodium hyaluronate in patients with knee pain.
Read the detailed description
CartiSave is a medical device composed of porcine-derived type II atelocollagen. Administered via intra-articular injection, it is intended to supplement collagen in damaged articular cartilage.
This multi-center, randomized, single-blind, active-controlled, parallel-group clinical trial is designed to evaluate the efficacy and safety of intra-articular CartiSave injection compared with sodium hyaluronate in patients with knee pain.
Efficacy is assessed using the 100 mm Pain Visual Analogue Scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) at baseline and at Weeks 4, 16, and 24. Safety is monitored throughout the 24-week period through adverse event reporting and physical evaluations.
- Conditions
- Osteoarthritis, Osteoarthritis Knee Pain, Knee Arthritis
- Being tested
- CartiSave, Hyalforte Injection
- Keywords
- Osteoarthritis, Knee Joint Pain, Intra-articular injection, Intra-articular collagen injection, Type 2 collagen
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CartiSaveDevice
Also called Collagen Supplement Intra articular injection
CartiSave is an intra-articular, collagen-based tissue supplement containing porcine-derived cartilage collagen. Administered via intra-articular injection, it is intended to supplement collagen in damaged articular cartilage. It is administered via intra-articular injection once weekly for 3 consecutive weeks (total of 3 injections).
Hyalforte InjectionDrug
Also called Sodium Hyaluronate Intra articular injection
Sodium hyaluronate is a viscoelastic intra-articular injection approved for the treatment of knee osteoarthritis. It is administered via intra-articular injection once weekly for 3 consecutive weeks (total of 3 injections).
| Study group | Role | What they receive |
|---|---|---|
| CartiSave (2mL) | Experimental | Not described Receives: Device: CartiSave |
| Sodium Hyaluronate(2mL) | Active comparator | Not described Receives: Drug: Hyalforte Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 100mm- VAS (during activity)
Knee joint pain during activity is assessed using a 100 mm Visual Analogue Scale (VAS). Scores range from 0 mm (no pain) to 100 mm
Measured: From Baseline to Week 16
Secondary outcomes (5)
Changes in 100mm- VAS Pain Score (during activity)
Knee joint pain during activity is assessed using a 100 mm Visual Analogue Scale (VAS). Scores range from 0 mm (no pain) to 100 mm(worst possible pain)
Measured: From Baseline to Week 4 and 24
Changes in 100mm- VAS Pain Score (at rest)
Resting pain in the target knee is assessed using a 100 mm Visual Analogue Scale (VAS). Scores range from 0 mm to 100 mm
Measured: From Baseline to Week 4, 16 and 24
Changes in K-WOMAC
Joint symptoms and physical function are assessed using the Korean Western Ontario and McMaster Universities (K-WOMAC) index, comprising pain, stiffness, and physical function subscales. Total scores range from 0 to 96, where lower scores indicate better knee joint health and symptom reduction.
Measured: From Baseline to Week 4, 16 and 24
Changes in SF-36
Health-related quality of life is assessed using the 36-Item Short Form Survey(SF-36), which covers physical functioning, bodily pain, general health, vitality, social functioning, and mental health. Scores for each domain range from 0 to 100, where higher scores represent a better health state and higher quality of life.
Measured: From Baseline to Week 4, 16 and 24
Changes in Use of Rescue Medication
The use of rescue medication (acetaminophen) will be assessed based on the average number of tablets taken. Lower usage indicates better pain control.
Measured: From Baseline to Day 0, Week 4, 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start27 Oct 2025
- Primary completion22 Jul 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATEMs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907926
- Sponsor's protocol ID
- AT-MD-01
- Acronym
- CartiSave
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Clinical Trial to Evaluate the Efficacy and Safety of 'CartiSave' in Patients With Knee Joint Pain
- ClinicalTrials.gov ID
- NCT07907926
- Acronym / sponsor ID
- CartiSave / AT-MD-01
- Conditions
- Osteoarthritis, Osteoarthritis Knee Pain, Knee Arthritis
- Keywords
- Osteoarthritis, Knee Joint Pain, Intra-articular injection, Intra-articular collagen injection, Type 2 collagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- ATEMsIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical trial is to evaluate the efficacy and safety of CartiSave compared with sodium hyaluronate in patients with knee pain.
Detailed description
CartiSave is a medical device composed of porcine-derived type II atelocollagen. Administered via intra-articular injection, it is intended to supplement collagen in damaged articular cartilage.
This multi-center, randomized, single-blind, active-controlled, parallel-group clinical trial is designed to evaluate the efficacy and safety of intra-articular CartiSave injection compared with sodium hyaluronate in patients with knee pain.
Efficacy is assessed using the 100 mm Pain Visual Analogue Scale (VAS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) at baseline and at Weeks 4, 16, and 24. Safety is monitored throughout the 24-week period through adverse event reporting and physical evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CartiSave (2mL) | Experimental | Device: CartiSave |
| Sodium Hyaluronate(2mL) | Active comparator | Drug: Hyalforte Injection |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Adults aged 19 years or older
- 2. Patients who agreed to participate in the study and signed the informed consent form
- 3. Patients whose target knee joint intended for investigational product injection meet all of the following conditions at the screening visit:
- 4. Patients who agree to use medically acceptable methods of contraception throughout the clinical trial period
Key exclusion criteria (19 listed)
- 1. Patients with a known hypersensitivity or history of allergic reactions to the active substance or any components of the investigational medical device or comparator drug (e.g., porcrine-derived proteins)
- 2. Patients or their family members with autoimmune diseases
- 3. Patients with inflammatory arthritis such as rheumatoid arthritis, lupus arthritis, or psoriatic arthritis
- 4. Patients with any of the following medical history or conditions at the screening visit:
- 5. Patients who use corticosteroids as follows at the screening visit:
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 |
|---|---|---|
| CartiSaveAlso: Collagen Supplement Intra articular injectionCartiSave is an intra-articular, collagen-based tissue supplement containing porcine-derived cartilage collagen. Administered via intra-articular injection, it is intended to supplement collagen in damaged articular cartilage. It is administered via intra-articular injection once weekly for 3 consecutive weeks (total of 3 injections). | Device | CartiSave (2mL) |
| Hyalforte InjectionAlso: Sodium Hyaluronate Intra articular injectionSodium hyaluronate is a viscoelastic intra-articular injection approved for the treatment of knee osteoarthritis. It is administered via intra-articular injection once weekly for 3 consecutive weeks (total of 3 injections). | Drug | Sodium Hyaluronate(2mL) |
Primary outcome
Changes in 100mm- VAS (during activity)
Time frame: From Baseline to Week 16
Knee joint pain during activity is assessed using a 100 mm Visual Analogue Scale (VAS). Scores range from 0 mm (no pain) to 100 mm
5 secondary outcomes
Changes in 100mm- VAS Pain Score (during activity)
Time frame: From Baseline to Week 4 and 24
Changes in 100mm- VAS Pain Score (at rest)
Time frame: From Baseline to Week 4, 16 and 24
Changes in K-WOMAC
Time frame: From Baseline to Week 4, 16 and 24
Changes in SF-36
Time frame: From Baseline to Week 4, 16 and 24
Changes in Use of Rescue Medication
Time frame: From Baseline to Day 0, Week 4, 16 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CartiSave and Hyalforte Injection in people with Osteoarthritis and Osteoarthritis Knee Pain, run by ATEMs at 4 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 8 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in 100mm- VAS (during activity) (time frame: From Baseline to Week 16). 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 30 Oct 2026.