Back to resultsClinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
Primary Purpose
Bone Marrow Edema
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
subchondroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Bone Marrow Edema
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)
Sites / Locations
- Gaetano Pini hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with subchondroplasty for bone edema in the knee
Arm Description
Patients treated with subchondroplasty for bone edema of the knee
Outcomes
Primary Outcome Measures
Pain reduction
Pain reduction of 4 points in numeric rating score
Secondary Outcome Measures
Radiological evaluation
Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren&Lawrence classification
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04905394
Brief Title
Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
Official Title
Short Term Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with subchondroplasty for bone edema in the knee
Arm Type
Experimental
Arm Description
Patients treated with subchondroplasty for bone edema of the knee
Intervention Type
Procedure
Intervention Name(s)
subchondroplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain reduction
Description
Pain reduction of 4 points in numeric rating score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radiological evaluation
Description
Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren&Lawrence classification
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
pietro randelli, prof
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaetano Pini hospital
City
Milano
State/Province
Lombardy
ZIP/Postal Code
20122
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Researcher will not share data with other organizations
Learn more about this trial
Clinical and Radiological Outcomes of Subchondroplasty in the Treatment of Bone Marrow Edema of the Knee
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