Study for the Treatment of Knee Chondral and Osteochondral Lesions
Condition: Knee Chondral Lesion; Knee Osteochondral Lesion
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Post-operative MRI exams will be carried out for each patient during the follow-up visit, at
      6, 12 and 24 months post-op., and centrally blind evaluated by two senior radiologists.

      STATISTICS The study has been designed to demonstrate the superiority of MaioRegen® compared
      to marrow stimulation techniques.

      On the basis of previous evidence and, assuming a minimum difference in the modification of
      the IKDC Subjective Knee Evaluation Score between MaioRegen® and the control therapy, the
      sample size was estimated in 74 patients for group (power=90%, first type error α=5%,
      drop-outs=10%), for a total sample size of 148 subjects.

      The analysis of the primary end-point will be the evaluation of change from baseline to two
      years, in IKDC Subjective Knee Evaluation Score, comparing the results between the two
      groups.

      Secondary end-points (functional improvement, quality of life improvement, tissue
      regeneration) will undergo the same analyses as the primary end-point, for each follow-up
      visit.

      Frequency tables will be provided for overall judgement of the treatment. The incidence and
      gravity frequency of eventual events after surgery will be tabulated.

      The study will be conducted after approval by the ethics committee board of each centre and
      possibly by the national competent authorities.
    

Intervention name(s): Marrow stimulation - Drilling or Microfractures; MaioRegen Surgery
Intervention type(s): Procedure; Device
Intervention description(s): 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.; 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.
Other intervention name(s): subchondral Drilling; Steadman's Microfractures; osteochondral scaffold
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CHONDRAL; OSTEOCHONDRAL