Knee Chondral Lesion Clinical Trial
Official title:
Multicenter Randomized Controlled Trial for the Treatment of Knee Chondral and Osteochondral Lesions: Marrow Stimulation Techniques vs MaioRegen
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment