Bone Marrow Edema Clinical Trial
Official title:
Short Term Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
NCT number | NCT04905394 |
Other study ID # | SubCond |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2017 |
Est. completion date | January 30, 2021 |
Verified date | May 2021 |
Source | University of Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 injected inside BML areas, ensuring stability and promoting the deposition of new bone. Primary outcome of this study was to obtain a reduction of the Numeric Rating Scale score of 4 points or more at 6 months follow-up in more than 75% of patients. The secondary outcome was to evaluate the osteoarthritic and bone marrow structure evolution in the months after the procedure.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 30, 2021 |
Est. primary completion date | January 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Italy | Gaetano Pini hospital | Milano | Lombardy |
Lead Sponsor | Collaborator |
---|---|
University of Milan |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain reduction | Pain reduction of 4 points in numeric rating score | 6 months | |
Secondary | Radiological evaluation | Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren&Lawrence classification | 6 months |
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