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

Study Overview
=================
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.

Official Title
-----------------
Short Term Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee

Conditions
-----------------
Bone Marrow Edema

Intervention / Treatment
-----------------
* Procedure: subchondroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with subchondroplasty for bone edema in the knee<br>Patients treated with subchondroplasty for bone edema of the knee | Procedure: subchondroplasty<br>* subchondroplasty is an innovative percutaneous procedure in which calcium phosphate, biocompatible material similar to the native bone apatite with osteoinductive properties, is injected inside BML areas. The purpose of subchondroplasty is the patient's symptoms relief, improving the mechanical strength of subchondral bone, stimulating bone remodeling to avoid bone sagging, and slow down the arthritic degenerative process to postpone arthroplasty.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | Pain reduction of 4 points in numeric rating score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological evaluation | Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren&Lawrence classification | 6 months |