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Study to Evaluate a New Cartilage Regeneration Platform for Knee Cartilage Repair (TCW)

24. juli 2026 oppdatert av: ROKIT Healthcare

A Prospective, Randomized, Multicenter, Open-Label, Assessor-Blinded, Parallel-Group Clinical Trial to Compare the Efficacy and Safety of Microfracture Alone Versus Microfracture Combined With a Cartilage Regeneration Platform in Patients With Knee Cartilage Defects

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?

Is the treatment safe and does it help grow stronger new cartilage?

Researchers will compare participants who get the standard surgery (microfracture) to participants who get both the standard surgery and the new treatment. This is to see if the new treatment leads to a better and faster recovery.

Participants will:

Have a surgery to treat their knee cartilage damage.

Visit the clinic for check-ups to see how well their knee moves.

Take imaging tests, like an MRI, so researchers can look at the new cartilage.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

104

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Sør -Korea
    • Daegu
      • Daegu, Daegu, Sør -Korea, 42415
        • Rekruttering
        • Yeungnam University Medical Center
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, Sør -Korea, 14647
        • Rekruttering
        • Catholic University of Korea Bucheon St. Mary's Hospital
      • Guri-si, Gyeonggi-do, Sør -Korea, 11923
        • Rekruttering
        • Hanyang University Guri Hospital
      • Gwangmyeong, Gyeonggi-do, Sør -Korea, 14220
        • Rekruttering
        • Chung-Ang University Gwangmyeong Hospital
      • Seongnam-si, Gyeonggi-do, Sør -Korea, 13620
        • Rekruttering
        • Bundang Seoul National University Hospital
    • Incheon
      • Goyang, Incheon, Sør -Korea, 21431
        • Har ikke rekruttert ennå
        • Catholic University of Korea Incheon St. Mary's Hospital
      • Incheon, Incheon, Sør -Korea, 21565
        • Rekruttering
        • Gachon University Gil Medical Center
      • Incheon, Incheon, Sør -Korea, 22332
        • Rekruttering
        • Inha University Hospital
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, Sør -Korea, 54907
        • Rekruttering
        • Jeonbuk National University Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Sør -Korea, 58128
        • Rekruttering
        • Chonnam National University Hwasun Hospital
    • Seoul
      • Seoul, Seoul, Sør -Korea, 5278
        • Rekruttering
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Seoul, Sør -Korea, 6973
        • Rekruttering
        • Chung-Ang University Hospital
      • Seoul, Seoul, Sør -Korea, 7804
        • Har ikke rekruttert ennå
        • Ewha Womans University Seoul Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion 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.

Exclusion Criteria:

  • 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 disease; severe liver or kidney disease; uncontrolled endocrine disease, etc.).
  • 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 will be no impact on study conduct during the study period).
  • 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 cruciate ligament, medial collateral ligament, or lateral collateral ligament).
  • 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 critical defects.
  • 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 inhibitors, etc.).
  • 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:

    1. Sterilization procedure of the participant or partner (vasectomy; bilateral oophorectomy and salpingectomy/tubal ligation; hysterectomy)
    2. Intrauterine device (IUD), including copper IUD or hormone-releasing intrauterine system
    3. Non-oral hormonal contraception or spermicide used in combination with a barrier method
    4. 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Control
only Microfracture on Knee cartilage defect site
Fremgangsmåte: Micronfracture
This intervention consists of arthroscopic debridement of the focal cartilage defect followed by microfracture performed at the defect bed according to standard technique. The study evaluates clinical and structural outcomes following microfracture.
Eksperimentell: Test
Microfracture with Micronized Auotologous ExtraCellular Matrix
Fremgangsmåte: MAECM transplantation
This intervention is a multi-step, autologous tissue-based regenerative procedure. Arthroscopic debridement is first performed at the focal cartilage defect. Microfracture is then performed at the defect bed according to standard technique. Infrapatellar fat pad (IFP) tissue is subsequently harvested through a small incision. The harvested autologous tissue is processed intra-operatively to generate micronized autologous ECM and prepared as a printable formulation. A patient-specific patch is fabricated using a 3D bioprinting system and implanted to cover the focal cartilage defect. The study evaluates patch integration and regenerative outcomes following implantation.
Andre navn:
  • Dr.INVIVO
  • AID REGEN
  • AI REGEN

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) total score at 1year
Tidsramme: Baseline to 12 months
Baseline to 12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) total score, assessed at 3, 6, and 9 months
Tidsramme: Baseline, 3 months, 6 months, and 9 months
Baseline, 3 months, 6 months, and 9 months
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score assessed by an independent evaluator at 6 and 12 months
Tidsramme: Baseline, 6 months, and 12 months
Baseline, 6 months, and 12 months
Change from baseline in 100-mm Visual Analog Scale (VAS) pain score at 3, 6, 9, and 12 months
Tidsramme: Baseline, 3 months, 6 months, 9 months, and 12 months
Baseline, 3 months, 6 months, 9 months, and 12 months
Change from baseline in International Knee Documentation Committee (IKDC) score at 3, 6, 9, and 12 months
Tidsramme: Change from baseline in IKDC
Change from baseline in IKDC

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ROKIT Healthcare

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. desember 2025

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. september 2027

Datoer for studieregistrering

Først innsendt

5. juni 2026

Først innsendt som oppfylte QC-kriteriene

5. juni 2026

Først lagt ut (Faktiske)

10. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • B-2511-1011-003

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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