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

NCT04905394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-05-27

No results posted yet for this study

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

  • Bone Marrow Edema

Interventions

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.

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • pietro randelli, prof · University of Milan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2020-01-30
Completion
2021-01-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04905394 on ClinicalTrials.gov