Study for the Treatment of Knee Chondral and Osteochondral Lesions
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.
|Knee Chondral Lesion Knee Osteochondral Lesion||Procedure: Marrow stimulation - Drilling or Microfractures Device: MaioRegen Surgery||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Multicenter Randomized Controlled Trial for the Treatment of Knee Chondral and Osteochondral Lesions: Marrow Stimulation Techniques vs MaioRegen|
- IKDC Subjective Knee Evaluation Form-2000 [ Time Frame: two years ]
- IKDC Knee Examination Form-2000 [ Time Frame: six months and one year ]
- KOOS [ Time Frame: six months, one year, two years ]
- Tegner score [ Time Frame: six months, one year, two years ]
- VAS (Visual Analogue Scale) for pain evaluation [ Time Frame: six months, one year, two years ]
- MRI exam and MOCART score [ Time Frame: six months, one year, two years ]
|Study Start Date:||January 2011|
|Study Completion Date:||February 2016|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
|Active Comparator: Marrow stimulation||
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.
|Experimental: Medical device: MaioRegen||
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.
Other Name: osteochondral scaffold
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282034
|AKH University Hospital|
|Gent Univeristy Hospital|
|Ghent, Belgium, B-9000|
|University Medical Center|
|Freiburg im Breisgau, Germany, 79098|
|Ospedal Sacro Cuore Don Calabria|
|Negrar, Verona, Italy, 37024|
|Istituti Ortopedici Rizzoli|
|Bologna, Italy, 40136|
|Oslo University Hospital HF|
|District hospital of orthopaedics|
|Piekary Slaskie, Katowice, Poland|
|Sport Science Orthopaedic Clinic|
|CapeTown, South Africa|
|Kungsbacka, Sweden, 43440|
|Zurich, Switzerland, 8008|
|Principal Investigator:||Maurilio Marcacci, Prof.||Istituti Ortopedici Rizzoli|