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Study for the Treatment of Knee Chondral and Osteochondral Lesions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fin-Ceramica Faenza Spa
ClinicalTrials.gov Identifier:
NCT01282034
First received: January 21, 2011
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Knee Chondral Lesion
Knee Osteochondral Lesion
Procedure: Marrow stimulation - Drilling or Microfractures
Device: MaioRegen Surgery
Phase 4

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

Further study details as provided by Fin-Ceramica Faenza Spa:

Primary Outcome Measures:
  • IKDC Subjective Knee Evaluation Form-2000 [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IKDC Knee Examination Form-2000 [ Time Frame: six months and one year ] [ Designated as safety issue: No ]
  • KOOS [ Time Frame: six months, one year, two years ] [ Designated as safety issue: No ]
  • Tegner score [ Time Frame: six months, one year, two years ] [ Designated as safety issue: No ]
  • VAS (Visual Analogue Scale) for pain evaluation [ Time Frame: six months, one year, two years ] [ Designated as safety issue: No ]
  • MRI exam and MOCART score [ Time Frame: six months, one year, two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Names:
  • subchondral Drilling
  • Steadman's Microfractures
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282034

Locations
Austria
AKH University Hospital
Wien, Austria
Belgium
Gent Univeristy Hospital
Ghent, Belgium, B-9000
Germany
University Medical Center
Freiburg im Breisgau, Germany, 79098
Italy
Ospedal Sacro Cuore Don Calabria
Negrar, Verona, Italy, 37024
Istituti Ortopedici Rizzoli
Bologna, Italy, 40136
Norway
Oslo University Hospital HF
Oslo, Norway
Poland
District hospital of orthopaedics
Piekary Slaskie, Katowice, Poland
South Africa
Sport Science Orthopaedic Clinic
CapeTown, South Africa
Sweden
Kungsbacka Hospital
Kungsbacka, Sweden, 43440
Switzerland
Schulthess Klinik
Zurich, Switzerland, 8008
Sponsors and Collaborators
Fin-Ceramica Faenza Spa
Investigators
Principal Investigator: Maurilio Marcacci, Prof. Istituti Ortopedici Rizzoli
  More Information

No publications provided

Responsible Party: Fin-Ceramica Faenza Spa
ClinicalTrials.gov Identifier: NCT01282034     History of Changes
Other Study ID Numbers: ORT-12
Study First Received: January 21, 2011
Last Updated: June 20, 2014
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Austria: Federal Office for Safety in Health Care
Austria: Ethikkommission
Belgium: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Norway: Directorate of Health
Norway: Ethics Committee
Sweden: Regional Ethical Review Board
Switzerland: Ethikkommission
Poland: Ethics Committee
South Africa: Human Research Ethics Committee

Keywords provided by Fin-Ceramica Faenza Spa:
CHONDRAL
OSTEOCHONDRAL

ClinicalTrials.gov processed this record on November 25, 2014