Engineered for orthopaedic surgery
“A system tailored to your patients’ needs”
MaioRegen is available in three different configurations:
MaioRegen Slim for the treatment of osteochondral lesions with slightly compromised subchondral bone
MaioRegen Chondro+ for the treatment of cartilage lesions
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”.
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.
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)
Osteochondritis Dissecans (OCD)
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.
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
Tegner Score – 96 months follow-up
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 Prime, MaioRegen Slim and MaioRegen Chondro+ represent specific solutions for the treatment of the different phases of early phases of arthritic pathology.
Calcified cartilage and sub-chondral bone layer
Spongy bone layer
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
B) Maioregen fits perfectly into lesion site, restoring anatomic continuity
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
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
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