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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Lesion of Articular Cartilage of Knee
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Andrea Mocci
  • Torino, Italy, 10132
    • Luisangelo Sordo
  • Ravenna
    • Cotignola, Ravenna, Italy, 48010
      • Raul Zini
    • Faenza, Ravenna, Italy, 48018
      • Maurizio Bellettato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
knee surgery	Procedure: knee surgery; Reparative, replacement or regenerative techniques, with or without associated osteotomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score	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.	12 months post procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
functional recovery at International Knee Documentation Committee(IKDC) knee Examination	12 months
Physical performance at Tegner activity score	12 months post surgery
functional activity on the Lysholm Knee Scale	12 months post surgery
Tissue regeneration at magnetic resonance (MRI)	12 months post surgery

Collaborators and Investigators

• Sponsor: Ettore Sansavini Health Science Foundation
• 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

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: March 12, 2012
• First Submitted That Met QC Criteria: March 14, 2012
• First Posted (Estimate): March 15, 2012

Study Record Updates

• Last Update Posted (Estimate): October 3, 2016
• Last Update Submitted That Met QC Criteria: September 30, 2016
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: osteochondral defect of the knee
• Other Study ID Numbers: ESREFO08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO