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MaioRegen Prime Studie zur Behandlung tiefer osteochondraler Läsionen des Knies (OSTEOCONFIRM)

3. Oktober 2026 aktualisiert von: Fin-Ceramica Faenza Spa

Multizentrische prospektive randomisierte Studie von MaioRegenTM Prime vs. Debridement (Chirurgischer Standard der Versorgung (SSOC)) für die Behandlung von osteochondralen Läsionen des Kniegelenks - OSTEOCONFIRM-Studie

The present study aims to compare the efficacy and the safety of MaioRegen Prime to Debridement (SSOC) in patients with deep osteochondral lesions of the knee joint. The foreseen population involves patients with osteochondral lesions with different etiology, dimension, shape, and location.

The evaluation will be performed through clinical, subjective and objective assessments.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This is multicenter, prospective, randomized clinical trial, subjects will be randomized (2:1) to MaioRegen Prime or debridement.

All randomized patients will be followed with post-operative visits at 15 days, 6 weeks, 3, 6, 12, 18 and 24 months after surgery and annually post-24 months visit (until last patient reaches 24 months).

During screening period and at follow-up visits commonly used specific scores will be evaluated: IKDC Subjective Knee Evaluation Form, IKDC Knee Examination Form, KOOS, Tegner Score, VAS pain, PROMIS-29, ICRS Cartilage Repair Assessment and MRI related scores.

Studientyp

Interventionell

Einschreibung (Geschätzt)

400

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Simal Trikam, Clinical Trial Manager
  • Telefonnummer: +44 7889983972
  • E-Mail: strikam@mcra.com

Studieren Sie die Kontaktsicherung

Studienorte

  • Italien
    • BO
      • Bologna, BO, Italien, 40136
        • Rekrutierung
        • IRCCS Rizzoli Orthopedic Institute
        • Hauptermittler:
          • Stefano Zaffagnini
  • Vereinigte Staaten
    • California
      • La Mesa, California, Vereinigte Staaten, 91942
        • Noch keine Rekrutierung
        • Grossmont Orthopaedic Medical Group
        • Hauptermittler:
          • Scott Hacker
    • Colorado
      • Steamboat Springs, Colorado, Vereinigte Staaten, 80487
        • Rekrutierung
        • Steamboat Orthopaedic & Spine Institute
        • Hauptermittler:
          • Alexander Meininger
    • Illinois
      • Oak Brook, Illinois, Vereinigte Staaten, 60523
        • Rekrutierung
        • Genesis Orthopedics & Sports Medicine
        • Hauptermittler:
          • Hythem Shadid
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • Rekrutierung
        • University of Michigan Med school
        • Hauptermittler:
          • John Grant
    • Ohio
      • Cincinnati, Ohio, Vereinigte Staaten, 45219
        • Rekrutierung
        • University of Cincinnati Medical Center
        • Hauptermittler:
          • Brian Grawe
      • Columbus, Ohio, Vereinigte Staaten, 43210
        • Rekrutierung
        • Ohio State University
        • Hauptermittler:
          • David Flanigan
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Rekrutierung
        • Oregon Health & Science University in Portland
        • Hauptermittler:
          • Dennis Charles Crawford
    • Tennessee
      • Jackson, Tennessee, Vereinigte Staaten, 38305
        • Rekrutierung
        • Clinical Research Solutions
        • Hauptermittler:
          • Jason Hutchison
    • Texas
      • Rockwall, Texas, Vereinigte Staaten, 75087
        • Rekrutierung
        • North Texas Medical Research Institute
        • Hauptermittler:
          • Mohammad Umar Burney

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Informed consent prior to any study-related procedures;
  2. Male or female patients aged between 18 and 60 years (inclusive);
  3. Body Mass Index (BMI) ≤ 35;
  4. Up to 3 treatable osteochondral lesions localized in femoral condyles and/or trochlea (the patient might have other lesion in other parts of the joint, but they should not be more severe than ICRS Grade II lesions as determined by baseline MRI);
  5. Knee osteochondral lesion(s) (Grade IVa and IVb according to ICRS Classification) or not re-fixable knee Osteochondritis Dissecans lesions as determined by baseline MRI;
  6. Lesions with an overall treatable area 1-7 cm2 (as determined by baseline MRI). In case of multiple lesions (maximum 3 lesions) in the same knee compartment a minimum distance of 3 mm is required);
  7. IKDC Subjective score at baseline (pre-op evaluation) is less than 70;
  8. Non-responsive to physical therapy for at least 6 weeks;
  9. Patients physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits.

Exclusion Criteria:

  1. IKDC subjective score at Baseline is more than or equal to 70;
  2. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain = 0, pain free = 100);
  3. Osteochondral tibial plateau and/or patella defects;
  4. Patients affected by advanced osteoarthritis in the index knee (Kellgren and Lawrence classification 3 or 4);
  5. Bony defect depth deeper than 5 mm, according to baseline MRI, measured from the original subchondral bone plate level;
  6. Uncontained defects: lack of vital bone wall at least 2 mm thick, completely surrounding the lesion - based on MRI;
  7. Patients with untreated patellofemoral malalignment or who have undergone realignment procedures within 6 months;
  8. Patients with bone fracture or uncorrected malalignment more than 5 degrees varus or valgus according to standing X-ray.
  9. Patients previously treated for total or partial meniscectomy in the specific index knee compartments (more than 50% of the meniscus in the index compartments is missing);
  10. Patient requiring total or partial meniscectomy to be performed concomitantly, involving more than 50% of one or both menisci in the index knee compartment (lack of functional remaining meniscus, at least 5mm rim at the end of the procedure); and patient requiring ligamentoplasty and high tibial osteotomy (HTO) to be performed concomitantly;
  11. Untreated knee ligament instability or treated within 6 months;
  12. Kissing (counterposed) osteochondral lesions;
  13. Significant instability of the index knee according to IKDC Knee Examination Form 2000: Grade C (abnormal) or D (severely abnormal).
  14. Patients affected by any concomitant painful or disabling disease of the spine, hips, or lower limbs, including the contralateral knee, that would interfere with the evaluation of the index knee;
  15. Patients affected by bilateral knee lesions that need treatment;
  16. Intra-articular steroid injections within 3 months;
  17. Any previous cartilage repair procedure (such as: microfracture, Osteochondral autograft transplantation system (OATS), Autologous Matrix Induced Chondrogenesis, (AMIC), Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee within one year or debridement within 6 months;
  18. Patients affected by osteoporosis (established through x-ray tests, called DEXA scans, bone density, etc. Criteria for osteoporosis: T-score is < - 2.5 SD), chondrodysplasia, or osteogenesis imperfecta;
  19. Patients affected by known allergy to equine collagen or calcium-phosphates;
  20. Patients who underwent chemotherapy in the past 12 months;
  21. Patients with a known history of any significant systemic disease (such as but not limited to: HIV, hepatitis, HTLV, syphilis, coagulopathies, insulin dependent diabetes mellitus etc.) or affected by a significant malignancy;
  22. Participation in other clinical trials within 90 days prior to the study or concurrent with the study;
  23. Patient who is pregnant (or intends to become pregnant within one-year post-op) or breastfeeding;
  24. Known drugs or alcohol abuse;
  25. Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other);
  26. Any known history of intra-articular or osseous infection of the index knee;
  27. Patients affected by a known history of inflammatory arthropathy or crystal-deposition arthropathy;
  28. Prisoners;
  29. The existence of any surgical or medical condition that, in the judgement of the Investigator, might compromise patient safety or the outcome of the study;
  30. Any medical conditions or implants that would prevent the participant from undergoing an MRI, including but not limited to pacemakers, clips, cochlear implants, or metal shrapnel.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: MaioRegen Prime

Medical Device: MaioRegen Prime implant
Gerät: osteochondral scaffold implant

three layered biomimetic osteochondral scaffold implant for osteochondral lesions of the knee
Aktiver Komparator: Surgical Standard of Care (SSOC)

Debridement
Verfahren: SSOC

Debridement

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Superiority of MaioRegen Prime vs Debridement
Zeitfenster: baseline, 24 months

The primary endpoint is the success rate defined as a composite binary endpoint, where a patient is a success if they meet all of the following criteria:

  • At least a 15 points IKDC increase at 24 months
  • Lack of SAE related to MaioRegen treatment or debridement during the 24-month follow-up
  • Lack of related re-intervention after MaioRegen treatment or debridement during the 24-month follow-up
baseline, 24 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anteil der Patienten ohne schwerwiegende unerwünschte Ereignisse (SUEs), die mit der MaioRegen-Behandlung oder der Débridement-Behandlung während des 24-monatigen Nachbeobachtungszeitraums in Zusammenhang stehen
Zeitfenster: Ausgangswert, 24 Monate
Ausgangswert, 24 Monate
Anteil der Patienten ohne verwandten Re-Eingriff nach MaioRegen-Behandlung oder Debridement-Behandlung während der 24-monatigen Nachbeobachtungszeit
Zeitfenster: Baseline, 24 Monate
Baseline, 24 Monate
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score at 24 months of MaioRegen Prime compared to debridement
Zeitfenster: baseline, 24 months

Subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function.

The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100.

Higher scores indicate higher levels of function and lower levels of symptoms, (i.e., a better outcome).
baseline, 24 months
Rate of responder in IKDC Subjective Knee Evaluation at 24 months of MaioRegen Prime compared to debridement as defined as improvement in IKDC Subjective Knee Evaluation of ≥15 points
Zeitfenster: baseline, 24 months

The new IKDC Subjective Knee Evaluation Form, published in 2000, is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function. The IKDC Subjective Knee Evaluation Form is graded by adding the results of each item's scores, and then converting the result to a scale from 0 to 100. Higher scores indicate higher levels of function and lower levels of symptoms, (i.e., a better outcome).
baseline, 24 months
Change from baseline in average overall KOOS score (Knee Injury and Osteoarthritis Outcome Score)
Zeitfenster: baseline, 12, 18, and 24 months

KOOS score consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question uses a 0 (no problem/difficulty) to 4 (extreme problem/difficulty) response, which is then converted into the final 0-100 score for each subscale, indicating the percentage of the total possible score achieved, with 0 representing extreme knee problems (i.e., worse outcome) and 100 representing no knee problems (i.e., better outcome).
baseline, 12, 18, and 24 months
Change from pre-injury and from baseline in Tegner score
Zeitfenster: baseline, 12 months, 18 months, 24 months

Tegner activity level scale allows to know the level of physical activity carried out by the patients. Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10, where 0 is being on sick leave/disabled due to knee issues, and 10 is elite, international competitive sports.
baseline, 12 months, 18 months, 24 months
Change from baseline in IKDC (International Knee Documentation Committee) Knee Examination Objective Form
Zeitfenster: baseline, 12 months, 18 months, 24 months

The IKDC objective examination form uses a 0-100 scale, calculated by summing seven parameters related to knee function. The presence of effusions and degree of knee motion are assessed; the worst value of any of these parameters determines the final IKDC grade. There are four grades (A, B, C, D) that identify a knee rated as normal, near normal, abnormal, and severely abnormal, respectively.
baseline, 12 months, 18 months, 24 months
Change from baseline in VAS (visual analogue scale) pain
Zeitfenster: baseline, 12 months, 18 months, 24 months

The VAS scale is a 0-cm line tool to measure pain intensity, with "no pain" at 0 and "worst pain imaginable" at 10, where patients mark their pain level
baseline, 12 months, 18 months, 24 months
PROMIS-29 (Patient-Reported Outcomes Measurement Information System): Patient's QOL (quality of life) improvement
Zeitfenster: baseline, 12 months, 18 months and 24 months

The PROMIS-29 uses a T-score metric (mean 50, SD 10) to assess 7 domains (Physical Function, Fatigue, Depression, Anxiety, Pain Interference, Sleep Disturbance, and Social Participation) with 4 questions with an additional pain intensity numeric rating scale (NRS, 0-10 score). There is no total score, but each axis forms its own score.
baseline, 12 months, 18 months and 24 months
MRI evaluation: MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) 2.0 Knee Score
Zeitfenster: baseline, 12 months, 24 months

MOCART 2.0 score allows the assessment of both cartilage tissue repair and the structures surrounding it. It is a 0-100 point MRI-based system for evaluating cartilage repair, updating the original MOCART by focusing on nine key variables like defect filling (in 25% increments), integration to native cartilage, surface, signal intensity, bony changes (overgrowth/defect), marrow edema, and subchondral cysts. 100 represents the best score and a score of 0 represents the worst score.
baseline, 12 months, 24 months

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Safety Outcome
Zeitfenster: 24 monhs

Adverse Events rate per type, severity, seriousness, and relatedness to the treatment, including Serious Adverse Events and Serious Adverse Device Effect, Adverse Device Effect, Unanticipated Adverse Device Effect, Re-operations, Complaint and Treatment Failures up to 24 months will be evaluated and adjudicated by CEC members.
24 monhs

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fin-Ceramica Faenza Spa

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

30. April 2031

Studienabschluss (Geschätzt)

30. April 2031

Studienanmeldedaten

Zuerst eingereicht

7. Januar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Januar 2026

Zuerst gepostet (Tatsächlich)

12. Januar 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Oktober 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ORT-24

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

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