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

5. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

104

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control
only Microfracture on Knee cartilage defect site
Procedure: 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.
Eksperimentel: Test
Microfracture with Micronized Auotologous ExtraCellular Matrix
Procedure: 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 navne:
  • Dr.INVIVO
  • AID REGEN
  • AI REGEN

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from baseline KOOS total score at 1year
Tidsramme: Baseline to 12 months
Baseline to 12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Change from baseline in 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
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 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 IKDC score at 3, 6, 9, and 12 months
Tidsramme: Change from baseline in IKDC
Change from baseline in IKDC

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

ROKIT Healthcare

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. december 2025

Primær færdiggørelse (Anslået)

30. juni 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • B-2511-1011-003

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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