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

Bone Marrow Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905394
• Other study ID #: SubCond
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: January 30, 2021

Study information

• Verified date: May 2021
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bone Marrow Edema
• Edema

Intervention

Procedure:
• subchondroplasty
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.

Locations

Country	Name	City	State
Italy	Gaetano Pini hospital	Milano	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction	Pain reduction of 4 points in numeric rating score	6 months
Secondary	Radiological evaluation	Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren&Lawrence classification	6 months