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

This study is ongoing, but not recruiting participants.
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: May 18, 2014
Last verified: May 2014
  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: 20
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (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
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: NCT01554878

Locations
Italy
Raul Zini
Cotignola, Ravenna, Italy, 48010
Maurizio Bellettato
Faenza, Ravenna, Italy, 48018
Andrea Mocci
Bari, Italy, 70124
Luisangelo Sordo
Torino, Italy, 10132
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: May 18, 2014
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 November 25, 2014