Study for the Treatment of Knee Chondral and Osteochondral Lesions

Summary

INTRODUCTION Marrow stimulation techniques as subchondral drilling or microfractures represent ones of the most frequently used methods for chondral and osteochodral defects repair and considered as standard techniques.

MaioRegen® (Fin-Ceramica Faenza S.p.A., Italy) is a bioceramic, multi-layered scaffold, in a single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is able to promote the tissue regeneration in case of severe and large chondral/osteochondral lesions, otherwise difficult to treat, as previously demonstrated in vitro, in vivo and in a clinical study.

OBJECTIVES The present study proposes to compare MaioRegen® performances with respect to reference standard surgical techniques (microfractures and subchondral drilling) for the treatment of chondral/osteochondral lesions, in order to consolidate MaioRegen®, as innovative surgical approach.

STUDY DESIGN The clinical trial is multicenter, prospective, randomized, controlled, two-arm, single-blind and involves eleven European centres and 150 patients. Eligible subjects will be randomly allocated to one of the two treatment groups: control group, treated with marrow stimulation techniques, and treatment group, treated with MaioRegen® implant.

Patient defect will be evaluated pre-operatively and each patient enrolled must meet all the entry criteria for the trial. Before enrolment, each subject should declare his voluntary participation to the study by informed consent signature.

Arthroscopic control will be carried out immediately before the randomization and thus surgical treatment, to confirm the characteristics of the lesion to be treated and finalizing the recruitment.

For each patient 6, 12 and 24 months post-operative follow-up visits will be carried out and during each follow-up visit the Case Report Form (CRF) will be filled in the specific section.

Within the CRF, at each follow-up section, commonly used and specific scores will be assigned for the established end-points (IKDC, KOOS, Tegner Score, VAS, MRI Mocart Scoring System).

Patients selected will be randomized to undergo one of two study groups, as prescribed by the randomization list.

Conditions

• Knee Chondral Lesion
• Knee Osteochondral Lesion

Interventions

PROCEDURE

Marrow stimulation - Drilling or Microfractures

Subchondral drilling consists in penetration of the subchondral bone endplate and creation of holes, and it is mostly indicated for the treatment of osteochodral lesion. Microfractures (MF), according to Steadman's technique, are one of the most used first-line treatment for cartilage injuries, and commonly considered safe and effective.

DEVICE

MaioRegen Surgery

MaioRegen® (is a bioceramic, multi-layered scaffold, in a single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is able to promote the tissue regeneration in case of severe and large chondral/osteochondral lesions.

Sponsors & Collaborators

• Fin-Ceramica Faenza Spa

  lead INDUSTRY

Principal Investigators

• Maurilio Marcacci, Prof. · Istituti Ortopedici Rizzoli

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2015-09-30

Completion

2016-02-29

Countries

• Austria
• Belgium
• Germany
• Italy
• Norway
• Poland
• South Africa
• Sweden
• Switzerland

Study Locations