Study for the Treatment of Knee Chondral and Osteochondral Lesions

NCT01282034 | Completed Phase 4

• 1 other identifier: ORT-12
• Study Type: interventional
• Target: 145
• Locations: 9 countries
• Sites: 10

Brief 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.

Conditions

Knee Chondral Lesion; Knee Osteochondral Lesion

Keywords

CHONDRAL; OSTEOCHONDRAL

Outcome Measures

Primary Outcomes (1)

• IKDC Subjective Knee Evaluation Form-2000

  two years

Secondary Outcomes (5)

• IKDC Knee Examination Form-2000

  six months and one year

• KOOS

  six months, one year, two years

• Tegner score

  six months, one year, two years

• VAS (Visual Analogue Scale) for pain evaluation

  six months, one year, two years

• MRI exam and MOCART score

  six months, one year, two years

Study Arms (2)

Marrow stimulation

ACTIVE COMPARATOR

Procedure: Marrow stimulation - Drilling or Microfractures

Medical device: MaioRegen

EXPERIMENTAL

Device: MaioRegen Surgery

Interventions

Marrow stimulation - Drilling or Microfractures PROCEDURE

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.

Also known as: subchondral Drilling, Steadman's Microfractures

Marrow stimulation

MaioRegen Surgery DEVICE

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.

Also known as: osteochondral scaffold

Medical device: MaioRegen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients provided written informed consent;
• Patients aged between 18 and 60 years;
• Knee symptomatic chondral lesion of grade III/IV (according to Outerbridge Classification) or osteochondral lesion;
• Not re-fixable OCD lesions;
• Lesion between 2-9 cm2;
• Single lesion;
• Patients agreed to actively participate in the rehabilitation protocol and follow-up program;
• Male or female patients;
• Women of childbearing age had to use a proven method to prevent pregnancy, before the surgical treatment.

You may not qualify if:

• Patients incapable to understanding and will;
• Patients participating in previous, concurrent or not, trials (ongoing or completed within 3 months);
• Patients surgically treated for the same defect within one year;
• Known allergy to collagen or calcium-phosphates;
• Patients affected by malignancy;
• Patients affected by metabolic or thyroid disorders;
• Patients used to alcohol or drug (medication) abuse;
• Patients affected by advanced osteoarthritis (Kellgren-Lawrence grade ≥3);
• Patients affected by synovitis;
• Untreated patellofemoral malalignment;
• Varus or valgus malalignment exceeding 5°;
• Body Mass Index \> 30;
• Patients previously treated for total or partial meniscectomy (\>50% of the meniscus dimension);
• Multiple lesions;
• Kissing lesions;

Sponsors & Collaborators

• Fin-Ceramica Faenza Spa: lead

Study Sites (10)

AKH University Hospital

Vienna, Vienna, Austria

Location

Gent Univeristy Hospital

Ghent, B-9000, Belgium

Location

University Medical Center

Freiburg im Breisgau, Freiburg Im Breisgau, 79098, Germany

Location

Istituti Ortopedici Rizzoli

Bologna, Bologna, 40136, Italy

Location

Ospedal Sacro Cuore Don Calabria

Negrar, Verona, 37024, Italy

Location

Oslo University Hospital HF

Oslo, Norway

Location

District hospital of orthopaedics

Piekary Śląskie, Katowice, Poland

Location

Sport Science Orthopaedic Clinic

CapeTown, South Africa

Location

Kungsbacka Hospital

Kungsbacka, 43440, Sweden

Location

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Maurilio Marcacci, Prof.

  Istituti Ortopedici Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

SE (1); NO (1); AU (1); DE (1); IT (2); CH (1); PL (1); BE (1); ZA (1)