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400 Participants NeededMy employer runs this trial

MaioRegen Prime for Knee Cartilage Damage

(OSTEOCONFIRM Trial)

Recruiting at 1 trial location
RM
ST
Overseen BySimal Trikam, Clinical Trial Manager
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Fin-Ceramica Faenza Spa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with significant knee cartilage and bone damage (deep osteochondral lesions) who haven't improved after at least 6 weeks of physical therapy. Participants must have a BMI of 35 or less, up to three treatable lesions in specific parts of the knee, and be able to follow rehab instructions.

Inclusion Criteria

Informed consent prior to any study-related procedures
Body Mass Index (BMI) ≤ 35
IKDC Subjective score at baseline less than 70
See 6 more

Exclusion Criteria

IKDC subjective score at baseline ≥ 70
KOOS Pain Subscale score at baseline less than 20 or more than 65
Participation in other clinical trials within 90 days prior or concurrent
See 27 more

What Are the Treatments Tested in This Trial?

Interventions

  • MaioRegen Prime

Trial Overview

The study compares two treatments for deep knee cartilage and bone injuries: an implant called MaioRegen Prime versus standard care involving cleaning out damaged tissue (debridement). Patients are assessed using both clinical exams and their own reports on symptoms.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: MaioRegen PrimeExperimental Treatment1 Intervention
Group II: Surgical Standard of Care (SSOC)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fin-Ceramica Faenza Spa

Lead Sponsor

Trials
2
Recruited
240+

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