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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

Tracking Information
First Submitted Date March 12, 2012
First Posted Date March 15, 2012
Last Update Posted Date October 3, 2016
Study Start Date January 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2012)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01554878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 14, 2012)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IV
Official Title Observational Studies, Prospective, Multicenter, to Evaluate the Effect of Treatment of Knee Osteochondral Lesions of Outerbridge Grade III-IV
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.
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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Degenerative Lesion of Articular Cartilage of Knee
Intervention Procedure: knee surgery
Reparative, replacement or regenerative techniques, with or without associated osteotomy.
Study Groups/Cohorts knee surgery
Intervention: Procedure: knee surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 18, 2014)
20
Original Estimated Enrollment
 (submitted: March 14, 2012)
90
Actual Study Completion Date November 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01554878
Other Study ID Numbers ESREFO08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Ettore Sansavini Health Science Foundation
Study Sponsor Ettore Sansavini Health Science Foundation
Collaborators Not Provided
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
PRS Account Ettore Sansavini Health Science Foundation
Verification Date May 2014