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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Observational Studies, Prospective, Multicenter, to Evaluate the Effect of Treatment of Knee Osteochondral Lesions of Outerbridge Grade III-IV

Conditions
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Degenerative Lesion of Articular Cartilage of Knee

Intervention / Treatment
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* Procedure: knee surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| knee surgery<br> | Procedure: knee surgery<br>* Reparative, replacement or regenerative techniques, with or without associated osteotomy.<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteochondral defect of the knee