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

Not Applicable

Completed

• Conditions: Bone Marrow Edema
• Interventions: Procedure: subchondroplasty

• Registration Number: NCT04905394
• Lead Sponsor: University of Milan

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2020-01-30
• Study Completion: 2021-01-30
• Status Verified: 2021-05
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-26
• Last Update Submitted: 2021-05-26
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with subchondroplasty for bone edema in the knee	subchondroplasty	Patients treated with subchondroplasty for bone edema of the knee

Primary Outcome Measures

Name	Time	Method
Pain reduction	6 months	Pain reduction of 4 points in numeric rating score

Secondary Outcome Measures

Name	Time	Method
Radiological evaluation	6 months	Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren\&Lawrence classification

Trial Locations

Locations (1)

Gaetano Pini hospital; 🇮🇹 Milano, Lombardy, Italy