An interventional study of CartiSave and Hyalforte Injection in Osteoarthritis, Osteoarthritis Knee Pain and Knee Arthritis, sponsored by ATEMs. Completed at 4 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by ATEMs · Not applicable, Interventional, and Treatment
Among 101 studies in Osteoarthritis with a site in Korea, Republic of — 6 open to participants now, 11 under way, 3 of them phase 3. Osteoarthritis · Korea, Republic of.
Among the 101 studies in Osteoarthritis with a site in Korea, Republic of, this one is the 37th largest by enrollment of the 87 interventional ones, is one of 3 that started in 2025, is one of 28 with no phase, and was the 101st registered.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 117 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →6 of the 101 studies in Osteoarthritis with a site in Korea, Republic of are open now, in 12 countries. Each count lists the studies.
Of the 287 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 72 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →101 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 3 started in 2025.
Median enrollment 106 across the 87 interventional studies, 319 across the 14 observational. Of the 72 that completed or were terminated, 7 (10%) have results posted.
59 of 101 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with ATEMs as lead sponsor.
ATEMs has 1 study filed under Osteoarthritis — fewer than ten, so there is no comparison to draw.
2 of the studies in Osteoarthritis with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07267793DALIM TISSEN Co., Ltd.Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage | 2026-12 |
| NCT03626038Zimmer BiometPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System | 2026-12 |
Among the 101 studies in Osteoarthritis with a site in Korea, Republic of, from their registry updates:
The purpose of this clinical trial is to evaluate the efficacy and safety of CartiSave compared with sodium hyaluronate in patients with knee pain.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
3. Patients whose target knee joint intended for product injection meet all of the following conditions at the screening visit:
Exclusion Criteria:
4. Patients with any of the following medical history or conditions at the screening visit:
5. Patients who use as follows at the screening visit:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: CartiSave
Drug: Hyalforte 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).
Also known as: Collagen Supplement 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).
Also known as: Sodium Hyaluronate Intra articular injection
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
Time frame: From Baseline to Week 16
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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline to Day 0, Week 4, 16 and 24
Ran from Oct 2025 to primary completion in Jul 2026, 8 months.
Of 135 industry-sponsored interventional studies with no phase under Osteoarthritis, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 81. This study's 8 months is below that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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