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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01554878
First Posted: March 15, 2012
Last Update Posted: October 3, 2016
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.
Information provided by (Responsible Party):
Ettore Sansavini Health Science Foundation
March 12, 2012
March 15, 2012
October 3, 2016
January 2012
March 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01554878 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV
Observational Studies, Prospective, Multicenter, to Evaluate the Effect of Treatment of Knee Osteochondral Lesions of Outerbridge Grade III-IV
The purpose of the study is to evaluate prospectively the outcome of treatment interventions of knee osteochondral lesions Outerbridge grade III and IV.
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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
patients referred to the participating centers for the treatment of symptomatic degenerative lesions of the knee, which meet the following inclusion criteria
Degenerative Lesion of Articular Cartilage of Knee
Procedure: knee surgery
Reparative, replacement or regenerative techniques, with or without associated osteotomy.
knee surgery
Intervention: Procedure: knee surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2014
March 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01554878
ESREFO08
No
Not Provided
Plan to Share IPD: No
Ettore Sansavini Health Science Foundation
Ettore Sansavini Health Science Foundation
Not Provided
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
Ettore Sansavini Health Science Foundation
May 2014