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

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ClinicalTrials.gov Identifier: NCT01554878
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation

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

Condition or disease Intervention/treatment
Degenerative Lesion of Articular Cartilage of Knee Procedure: knee surgery

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.

Study Design
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Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
Official Title: Observational Studies, Prospective, Multicenter, to Evaluate the Effect of Treatment of Knee Osteochondral Lesions of Outerbridge Grade III-IV
Study Start Date : January 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : November 2014
Groups and Cohorts
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Group/Cohort Intervention/treatment
knee surgery Procedure: knee surgery
Reparative, replacement or regenerative techniques, with or without associated osteotomy.


Outcome Measures
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Primary Outcome Measures :
  1. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score [ Time Frame: 12 months post procedure ]
    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 :
  1. functional recovery at International Knee Documentation Committee(IKDC) knee Examination [ Time Frame: 12 months ]
  2. Physical performance at Tegner activity score [ Time Frame: 12 months post surgery ]
  3. functional activity on the Lysholm Knee Scale [ Time Frame: 12 months post surgery ]
  4. Tissue regeneration at magnetic resonance (MRI) [ Time Frame: 12 months post surgery ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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 lesions 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 visits.

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554878


Locations
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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
Investigators
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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
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Responsible Party: Ettore Sansavini Health Science Foundation
ClinicalTrials.gov Identifier: NCT01554878     History of Changes
Other Study ID Numbers: ESREFO08
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: May 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ettore Sansavini Health Science Foundation:
osteochondral defect of the knee