CompletedNot Applicable

Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee

Italy50 participantsStarted 2017-04-01

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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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)

What they're measuring

Pain reduction

Timeframe: 6 months

Trial details

NCT IDNCT04905394

SponsorUniversity of Milan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-30

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