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New treatment option for Cartilage Defects of the Knee
Official title Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair
ClinicalTrials.gov ID: NCT07639424
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if a new treatment works to help regrow knee cartilage in people with knee cartilage damage. The main questions it aims to answer are: Does the treatment help the knee work better and lower pain more than the standard surgery?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 64
You may be able to join if
- Adults aged 19 years to \<65 years at the time of consent.
- Cartilage lesion severity of the target knee is ICRS grade 3 or 4.
- Focal cartilage defect size in the target knee is ≥5 cm² and ≤10 cm².
- The target knee is clinically considered to require microfracture, or microfracture with high tibial osteotomy (HTO).
- Able and willing to provide written informed consent after receiving a full explanation of the study.
You likely can't join if
- Traumatic or secondary osteoarthritis (Secondary OA) in the target knee.
- Inflammatory arthritis in the target knee (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic...
- Currently receiving immunosuppressive therapy or having a serious systemic disease (e.g., severe cardiovascular disease; long-term use of...
- Advanced severe osteoarthritis in the target knee (Kellgren-Lawrence [KL] grade 4).
- Lower-limb malalignment that may affect the surgical plan (e.g., varus deformity with varus angle ≥15°).
- Within 5 years prior to Visit 1, a history of osteomyelitis of the target knee, a diagnosis of malignancy, or recurrent malignancy (participants with...
See the full eligibility criteria
- Adults aged 19 years to \<65 years at the time of consent.
- Cartilage lesion severity of the target knee is ICRS grade 3 or 4.
- Focal cartilage defect size in the target knee is ≥5 cm² and ≤10 cm².
- The target knee is clinically considered to require microfracture, or microfracture with high tibial osteotomy (HTO).
- Able and willing to provide written informed consent after receiving a full explanation of the study.
- Traumatic or secondary osteoarthritis (Secondary OA) in the target knee.
- Inflammatory arthritis in the target knee (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, gout, pseudogout, Behçet's disease, etc.).
- Currently receiving immunosuppressive therapy or having a serious systemic disease (e.g., severe cardiovascular disease; long-term use of immunosuppressants; cancer patient receiving chemotherapy; systemic autoimmune...
- Advanced severe osteoarthritis in the target knee (Kellgren-Lawrence [KL] grade 4).
- Lower-limb malalignment that may affect the surgical plan (e.g., varus deformity with varus angle ≥15°).
- Within 5 years prior to Visit 1, a history of osteomyelitis of the target knee, a diagnosis of malignancy, or recurrent malignancy (participants with benign tumors may be eligible if the investigator judges that there...
- Body mass index (BMI) ≥35 kg/m².
- Clinically significant knee instability in the target knee that is not expected to be improved by the study procedure (e.g., complete or partial tears of major ligaments such as the anterior cruciate ligament, posterior...
- Prior surgery for treatment of a cartilage defect in the target knee (diagnostic arthroscopy only is allowed).
- History of major structural surgery of the target knee (diagnostic arthroscopy only is allowed). Participants with prior HTO may be eligible at the investigator's discretion if the knee structure is stable without...
- Intra-articular injection of any biologic or pharmacologic agent into the target knee within 3 months prior to Visit 1 (e.g., hyaluronic acid, corticosteroids, platelet-rich plasma, autologous cell therapy, cytokine...
- Use of systemic corticosteroids within 1 month prior to Visit 1.
- Participant or partner is a woman of childbearing potential and the participant does not agree to use an effective method of contraception during the study period, including any of the following:
- Sterilization procedure of the participant or partner (vasectomy; bilateral oophorectomy and salpingectomy/tubal ligation; hysterectomy)
- Intrauterine device (IUD), including copper IUD or hormone-releasing intrauterine system
- Non-oral hormonal contraception or spermicide used in combination with a barrier method
- Cervical cap or diaphragm used in combination with a male condom
- Pregnant or breastfeeding.
- Participation in another clinical trial and receipt of an investigational medical device within 6 months prior to Visit 1.
- Any other condition that, in the opinion of the principal investigator (or delegated study staff), makes the participant unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Daegu, Daegu, South Korea
- Bucheon-si, Gyeonggi-do, South Korea
- Guri-si, Gyeonggi-do, South Korea
- Gwangmyeong, Gyeonggi-do, South Korea
- Seongnam-si, Gyeonggi-do, South Korea
- Goyang, Incheon, South Korea
- Incheon, Incheon, South Korea
- Jeonju, Jeollabuk-do, South Korea
- Hwasun, Jeollanam-do, South Korea
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daegu, Daegu, South Korea; Bucheon-si, Gyeonggi-do, South Korea; Guri-si, Gyeonggi-do, South Korea; Gwangmyeong, Gyeonggi-do, South Korea; Seongnam-si, Gyeonggi-do, South Korea; Goyang, Incheon, South Korea and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.