Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV (LOGIC)

This study is currently recruiting participants.
Verified July 2013 by Ettore Sansavini Health Science Foundation
Sponsor:
Collaborator:
Prof. Livio Tronconi
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier:
NCT01554878
First received: March 12, 2012
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to evaluate prospectively the outcome of treatment interventions of knee osteochondral lesions Outerbridge grade III and IV.


Condition Intervention
Degenerative Lesion of Articular Cartilage of Knee
Procedure: knee surgery

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Studies, Prospective, Multicenter, to Evaluate the Effect of Treatment of Knee Osteochondral Lesions of Outerbridge Grade III-IV

Further study details as provided by Ettore Sansavini Health Science Foundation:

Primary Outcome Measures:
  • International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score [ Time Frame: 12 months post procedure ] [ Designated as safety issue: No ]
    Primary outcome measure will be the outcome of innovative treatments with repairing, regenerative and replacement techniques, with or without associated osteotomy, of knee osteochondral severe lesions(Outerbridge grade III and IV) in terms of symptoms improvement as assessed by means of the International Knee Documentation Committee (IKDC) subjective Knee Evaluation Score at 12 months postoperatively.


Secondary Outcome Measures:
  • functional recovery at International Knee Documentation Committee(IKDC) knee Examination [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Physical performance at Tegner activity score [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
  • functional activity on the Lysholm Knee Scale [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]
  • Tissue regeneration at magnetic resonance (MRI) [ Time Frame: 12 months post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
knee surgery Procedure: knee surgery
Reparative, replacement or regenerative techniques, with or without associated osteotomy.

Detailed Description:

The main purpose of the study is to prospectively evaluate the outcome of treatment interventions with replacement, repair and regenerative approaches, of osteochondral articular lesions or defects, Outerbridge grade III and IV, in terms of symptomatic and functional recovery 12 months after surgery.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients referred to the participating centers for the treatment of symptomatic degenerative lesions of the knee, which meet the following inclusion criteria

Criteria

Inclusion criteria:

patients referred to the participating centers for symptomatic treatment of degenerative lesions of the knee, which meet the following inclusion criteria:

  • symptomatic osteochondral leasions of grade III or IV (according to classification of Outerbridge;
  • Axial deviation with chondral damage, correct or not;
  • Consent to the processing of personal data, signed and dated by patient;
  • Patients of both sexes and aged between 30 and 60 years;
  • Patients willing to participate actively in the rehabilitation program and to attend post-operative follow-up vists.

Exclusion criteria:

  • Patients with synovitis;
  • BMI> 30;
  • Allergy to collagen or calcium phosphate;
  • Patients with neoplastic disease;
  • Patients with metabolic disorders, thyroid diseases, immune system disorders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01554878

Contacts
Contact: Raul Zini, MD +39 0545 217644
Contact: Giulia Schiavina +39 0545 217032 gschiavina@esrefo.org

Locations
Italy
Raul Zini Recruiting
Cotignola, Ravenna, Italy, 48010
Contact: Raul Zini, MD    +39 0545 217644    raulzini@aliceposta.it   
Contact: Giulia Schiavina    +39 0545 217032    gschiavina@esrefo.org   
Principal Investigator: Raul Zini, MD         
Sub-Investigator: Andrea Carraro, MD         
Maurizio Bellettato Recruiting
Faenza, Ravenna, Italy, 48018
Contact: Maurizio Bellettato, MD    +39 0546 671111      
Contact: Giulia Schiavina    +39 0545 217032    gschiavina@esrefo.org   
Sub-Investigator: Paribelli, MD         
Principal Investigator: Maurizio Bellettato, MD         
Andrea Mocci Recruiting
Bari, Italy, 70124
Contact: Andrea Mocci, MD    +39 080 5644570    andreamocci@virgilio.it   
Contact: Roberta Spirito    +39 080 5644127    rspirito@esrefo.org   
Sub-Investigator: Michele Di Palo, MD         
Principal Investigator: Andrea Mocci, MD         
Sergio Avondo Recruiting
Catania, Italy, 95123
Contact: Sergio Avondo, MD    +39 095 350701    sergio.avondo@tin.it   
Contact: Clelia Iovino    +39 091 6981325    ciovino@esrefo.org   
Sub-Investigator: Giuseppe Condorelli, MD         
Principal Investigator: Sergio Avondo, MD         
Rodolfo Rocchi Recruiting
Reggio Emilia, Italy, 42123
Contact: Rodolfo Rocchi, MD    +39 0522 499111    rocchi.rodolfo@virgilio.it   
Sub-Investigator: Calogero Giaimo, MD         
Principal Investigator: Rodolfo Rocchi, MD         
Luisangelo Sordo Recruiting
Torino, Italy, 10132
Contact: Luisangelo Sordo, MD    +39 011 8967111    lsordo@gvmnet.it   
Contact: Annarita Zeoli    +39 011 8967446    azeoli@esrefo.org   
Sub-Investigator: Giuseppe Gerbi Gerbi, MD         
Principal Investigator: Luisangelo Sordo, MD         
Sponsors and Collaborators
Ettore Sansavini Health Science Foundation
Prof. Livio Tronconi
Investigators
Study Director: Raul Zini, MD Maria Cecilia Hospital
Principal Investigator: Luisangelo Sordo, MD MARIA PIA HOSPITAL
Principal Investigator: Maurizio Bellettato, MD SAN PIER DAMIANO
Principal Investigator: Andrea Mocci, MD ANTHEA HOSPITAL
  More Information

No publications provided

Responsible Party: Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier: NCT01554878     History of Changes
Other Study ID Numbers: ESREFO08
Study First Received: March 12, 2012
Last Updated: July 30, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Ettore Sansavini Health Science Foundation:
osteochondral defect of the knee

ClinicalTrials.gov processed this record on April 17, 2014