Clinical Trials Directory

Trials / Completed

CompletedNCT04905394

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
50 (actual)
Sponsor
University of Milan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREsubchondroplastysubchondroplasty 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.

Timeline

Start date
2017-04-01
Primary completion
2020-01-30
Completion
2021-01-30
First posted
2021-05-27
Last updated
2021-05-27

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04905394. Inclusion in this directory is not an endorsement.