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.
| Status | Completed |
| Enrollment | 145 |
| Est. completion date | February 2016 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: 1. Patients provided written informed consent; 2. Patients aged between 18 and 60 years; 3. Knee symptomatic chondral lesion of grade III/IV (according to Outerbridge Classification) or osteochondral lesion; 4. Not re-fixable OCD lesions; 5. Lesion between 2-9 cm2; 6. Single lesion; 7. Patients agreed to actively participate in the rehabilitation protocol and follow-up program; 8. Male or female patients; 9. Women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment. Exclusion Criteria: 1. Patients incapable to understanding and will; 2. Patients participating in previous, concurrent or not, trials (ongoing or completed within 3 months); 3. Patients surgically treated for the same defect within one year; 4. Known allergy to collagen or calcium-phosphates; 5. Patients affected by malignancy; 6. Patients affected by metabolic or thyroid disorders; 7. Patients used to alcohol or drug (medication) abuse; 8. Patients affected by advanced osteoarthritis (Kellgren-Lawrence grade =3); 9. Patients affected by synovitis; 10. Untreated patellofemoral malalignment; 11. Varus or valgus malalignment exceeding 5°; 12. Body Mass Index > 30; 13. Patients previously treated for total or partial meniscectomy (>50% of the meniscus dimension); 14. Multiple lesions; 15. Kissing lesions; 16. Chondral/osteochondral tibial plate defects; 17. Concomitant menisci and chondral/osteochondral defects to be treated; 18. Untreated knee ligament instability. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | AKH University Hospital | Wien | |
| Belgium | Gent Univeristy Hospital | Ghent | |
| Germany | University Medical Center | Freiburg im Breisgau | |
| Italy | Istituti Ortopedici Rizzoli | Bologna | |
| Italy | Ospedal Sacro Cuore Don Calabria | Negrar | Verona |
| Norway | Oslo University Hospital HF | Oslo | |
| Poland | District hospital of orthopaedics | Piekary Slaskie | Katowice |
| South Africa | Sport Science Orthopaedic Clinic | CapeTown | |
| Sweden | Kungsbacka Hospital | Kungsbacka | |
| Switzerland | Schulthess Klinik | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| Fin-Ceramica Faenza Spa |
Austria, Belgium, Germany, Italy, Norway, Poland, South Africa, Sweden, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | IKDC Subjective Knee Evaluation Form-2000 | two years | No | |
| Secondary | IKDC Knee Examination Form-2000 | six months and one year | No | |
| Secondary | KOOS | six months, one year, two years | No | |
| Secondary | Tegner score | six months, one year, two years | No | |
| Secondary | VAS (Visual Analogue Scale) for pain evaluation | six months, one year, two years | No | |
| Secondary | MRI exam and MOCART score | six months, one year, two years | No |