Clinical trial NCT01554878: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Lesion of Articular Cartilage of Knee
Keywords: osteochondral defect of the knee
Lead sponsor: Ettore Sansavini Health Science Foundation
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Score
timeFrame: 12 months post procedure
Secondary outcomes:
measure: functional recovery at International Knee Documentation Committee(IKDC) knee Examination
timeFrame: 12 months
measure: Physical performance at Tegner activity score
timeFrame: 12 months post surgery
measure: functional activity on the Lysholm Knee Scale
timeFrame: 12 months post surgery
measure: Tissue regeneration at magnetic resonance (MRI)
timeFrame: 12 months post surgery
Other outcomes:
Locations:
city: Cotignola
country: Italy
facility: Raul Zini
state: Ravenna
city: Faenza
country: Italy
facility: Maurizio Bellettato
state: Ravenna
city: Bari
country: Italy
facility: Andrea Mocci
city: Torino
country: Italy
facility: Luisangelo Sordo
Study officials:
affiliation: Maria Cecilia Hospital
name: Raul Zini, MD
role: STUDY_DIRECTOR
affiliation: MARIA PIA HOSPITAL
name: Luisangelo Sordo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SAN PIER DAMIANO
name: Maurizio Bellettato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ANTHEA HOSPITAL
name: Andrea Mocci, MD
role: PRINCIPAL_INVESTIGATOR
References: