Status:
COMPLETED
All Autologous Cartilage Regeneration in the Treatment of the Knee Cartilage Defects
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Cartilage Damage
Cartilage Disease
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The cartilage articular defects of the knee are extremely disabling lesions and represent one of the predisposition causes to the development of articular arthrosis. When clinical symptoms are presen...
Detailed Description
The aim of the Pilot Study is to describe the clinical performance of the AACR technique in the treatment of the cartilage defects in terms of complications after surgery, quality of the repaired cart...
Eligibility Criteria
Inclusion
- Singular symptomatic chondral lesion classified as ICRS III or IV at the femoral condyle with less than 3 mm bone damage under the subchondral plate;
- Lesion between 1 and 8 cm2;
- BMI ≤ 34;
- Ability and will to actively participate in a strict rehabilitation protocol and follow-up.
Exclusion
- Previous cartilage operation on the injured knee
- Additional grade III or IV lesion on the same knee
- Previous arthroscopic treatments that affect the AACR technique
- Ligamentous/patellofemoral instability/malposition, varus or valgus malposition ≤3° which cannot be treated/corrected simultaneously
- Previous tendon repair, ligament reconstruction or realignment within the last 6 months
- Any known human immunodeficiency virus, hepatitis, syphilis, malignancy or uncontrolled diabetes
- Uncooperative patients who disregard or cannot follow instructions, including those who abuse drugs and/or alcohol
- Participation in a clinical drug or medical device trial that clinically interferes with the present observational study
- Inability to follow procedures (i.e. dementia)
- Inability to give consent
- No understanding of German language
- Pregnant or lactating women
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04785092
Start Date
March 1 2021
End Date
January 21 2025
Last Update
March 6 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40124