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

U

University of Milan

Status

Completed

Conditions

Bone Marrow Edema

Treatments

Procedure: subchondroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT04905394
SubCond

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Treatment with subchondroplasty for bone edema in the knee
Experimental group
Description:
Patients treated with subchondroplasty for bone edema of the knee
Treatment:
Procedure: subchondroplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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