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

Ettore Sansavini Health Science Foundation20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Degenerative Lesion of Articular Cartilage of Knee

Interventions

knee surgeryPROCEDURE

Reparative, replacement or regenerative techniques, with or without associated osteotomy.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (4)

Andrea Mocci

Bari, Bari, Italy

Raul Zini

Cotignola, Ravenna, Italy

Maurizio Bellettato

Faenza, Ravenna, Italy

Luisangelo Sordo

Torino, Torino, Italy

Outcomes

Primary Outcomes

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.

Time frame: 12 months post procedure

Secondary Outcomes

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

Data from ClinicalTrials.gov

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