To Top

MAIOREGEN
OSTEOCHONDRAL SUBSTITUTE

Engineered for orthopaedic surgery

MaioRegen is a new therapeutic concept, inspired by nature and shaped by state-of-the-art Nanotechnologies. It promotes and guides an effective bone and cartilage regeneration, thus restoring the natural joint physiology.

“A system tailored to your patients’ needs”

MaioRegen is available in three different configurations:

MaioRegen Prime for the treatment of osteochondral lesions with severely compromised subchondral bone

MaioRegen Slim for the treatment of osteochondral lesions with slightly compromised subchondral bone

MaioRegen Chondro+ for the treatment of cartilage lesions
Image

Key Features

Lesions of the joint surface are a very common clinical challenge, frequently diagnosed also in young people. If untreated, they may degenerate into chronic, disabling conditions that can be addressed only by an invasive approach.

In most cases, articular cartilage damage implies the simultaneous suffering of the sub-chondral bone structure. To guarantee the successful restoration of a healthy and functional joint, we should go “to the core of the problem”.

Indications

MaioRegen Prime (tri-layer) is indicated for the treatment of single/multiple osteochondral lesions with severely compromised bone, Outerbridge Grade IV. Lesions can be f traumatic, post-traumatic or degenerative origin, as well as caused by osteochondritis dissecans (OCD).

MaioRegen Slim (bi-layer) is indicated for the treatment of single/multiple osteochondral lesions with slightly compromised bone, Outerbridge Grade III and IV. Lesions can be f traumatic, post-traumatic or degenerative origin.

Both devices are also indicated for Early OA lesions, Grade I/II according to Kellgren&Lawrence, in absence of osteophytes and depending on the level of bone involvement.

MaioRegen Chondro+ is indicated for the treatment of single/multiple chondral lesions, with no or slight alteration of the subchondral bone, Outerbridge Grade III and IV. Lesions can be f traumatic, post-traumatic or degenerative origin.
Image

Clinical Evidence

To date, more than 4.000 patients have been treated with MaioRegen, which is considered an effective and safe treatment.

A randomized controlled clinical trial (RCT) vs. microfracture (Level of Evidence 1) shows a statistical significant improvement in the clinical scores (IKDC Subjective, Tegner, KOOS, VAS) at 2 years follow-up.

MaioRegen has proven to be superior to microfracture in the following indications: deep osteochondral lesions, osteochondritis dissecans (OCD) and in the population of sport active patients.

Deep Osteochondral Lesions (Outerbridge Grade IV)

Statistically significant superiority of MaioRegen vs. Microfracture (+12.4 points in change from baseline for IKDC subjective score).
Image
Image

Osteochondritis Dissecans (OCD)

Superiority of 12 points in change from baseline of MaioRegen vs. Microfracture in IKDC Subjective score.

Sport Active Patients

 Statistically significant superiority of MaioRegen vs. Microfracture (+16 points in change from baseline for IKDC subjective score).

Superiority of MaioRegen treatment in these populations provides clear indications for the treatment of osteochondral lesions with MaioRegen Prime.

Image

Moreover, a pilot study with 27 patients shows the stability of clinical scores at 8 year of follow-up, in patients suffering from complex lesions treated with MaioRegen

 
Subjective IKDCX – 96 months follow-up
Image
Tegner Score – 96 months follow-up
Image

Technical Specification

Composition and structure

MaioRegen is a multi-layered matrix, manufactured through a patented process.

The product, composed by collagen and hydroxyapatite enriched with magnesium, mimics the chondral and osteochondral tissues, both in the chemical composition and in the micro- and nano-structure.

MaioRegen is available in three different configurations: MaioRegen PrimeMaioRegen Slim and MaioRegen Chondro+ represent specific solutions for the treatment of the different phases of early phases of arthritic pathology.

Image

Biomimetism

Cartilage layer

Calcified cartilage and sub-chondral bone layer

Spongy bone layer

 

  • 01 D Gtr A
    A) The damaged tissue is removed to create a suitable lodging to host the implant and guarantee an adequate blood flow from the subchondral bone
  • 02 D Gtr A
    B) Maioregen fits perfectly into lesion site, restoring anatomic continuity
  • 03 D Gtr A
    C) The biomimetic porous structure and the chimical composition favour cellular migration. The bone marrow-derived cells selectively adhere to the collagen fibres, colonizing the entire scaffold
  • 04 D Gtr A
    D) Cells proliferate, differentiate and synthesize matrix according to scaffold layer composition. The progressive resorption of MaioRegen and the simultaneous cell mediated remodeling favour the complete regeneration of the tissue

    Publications

    Videos

    Follow us on social media

    Related Products

    Sign in to your account

    We use cookies

    We use cookies on our website. Some of them are essential for the operation of the site, while others help us to improve this site and the user experience (tracking cookies). You can decide for yourself whether you want to allow cookies or not. Please note that if you reject them, you may not be able to use all the functionalities of the site.