Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV (LOGIC)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01554878 |
Recruitment Status :
Completed
First Posted : March 15, 2012
Last Update Posted : October 3, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Degenerative Lesion of Articular Cartilage of Knee | Procedure: knee surgery |
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 |
Group/Cohort | Intervention/treatment |
---|---|
knee surgery |
Procedure: knee surgery
Reparative, replacement or regenerative techniques, with or without associated osteotomy. |
- 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.
- functional recovery at International Knee Documentation Committee(IKDC) knee Examination [ Time Frame: 12 months ]
- Physical performance at Tegner activity score [ Time Frame: 12 months post surgery ]
- functional activity on the Lysholm Knee Scale [ Time Frame: 12 months post surgery ]
- Tissue regeneration at magnetic resonance (MRI) [ Time Frame: 12 months post surgery ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

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
Italy | |
Raul Zini | |
Cotignola, Ravenna, Italy, 48010 | |
Maurizio Bellettato | |
Faenza, Ravenna, Italy, 48018 | |
Andrea Mocci | |
Bari, Italy, 70124 | |
Luisangelo Sordo | |
Torino, Italy, 10132 |
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 |
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 |
osteochondral defect of the knee |