Status:
COMPLETED
Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
Lead Sponsor:
University of Milan
Conditions:
Bone Marrow Edema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Bone marrow lesions (BMLs) of the knee are common subchondral defects, often associated with pain and functional limitation. Subchondroplasty is a percutaneous procedure in which calcium phosphate is ...
Eligibility Criteria
Inclusion
- Atraumatic knee pain for at least 3 months;
- Failure of conservative treatment (including NSAIDs, physical therapy, intra- articular injection with steroids or hyaluronic acid and bisphosphonates);
- Mild to moderate osteoarthritis (Kellgren-Lawrence18 grade ≤ 3)
- BML on a loading area at MRI imaging (femoral condyles and/or tibial plateau)
Exclusion
- Knee pain and functional limitation related to other causes like osteonecrosis
- Fractures or inflammatory arthritis
- Ligamentous instabilities
- Malalignment on the coronal axis greater than 10 degrees in varus/valgus
- Severe tri-compartmental arthritis (Kellgren-Lawrence grade 4)
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04905394
Start Date
April 1 2017
End Date
January 30 2021
Last Update
May 27 2021
Active Locations (1)
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1
Gaetano Pini hospital
Milan, Lombardy, Italy, 20122