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

Sponsor

University of Milan (Other)

Overall Status

Completed

CT.gov ID

NCT04905394

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bone Marrow Edema	Procedure: subchondroplasty	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Jan 30, 2020

Actual Study Completion Date :

Jan 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment with subchondroplasty for bone edema in the knee Patients treated with subchondroplasty for bone edema of the knee	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.

Arm

Intervention/Treatment

Experimental: Treatment with subchondroplasty for bone edema in the knee

Patients treated with subchondroplasty for bone edema of the knee

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.

Outcome Measures

Primary Outcome Measures

Pain reduction [6 months]
Pain reduction of 4 points in numeric rating score

Secondary Outcome Measures

Radiological evaluation [6 months]
Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren&Lawrence classification

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaetano Pini hospital	Milano	Lombardy	Italy	20122

Sponsors and Collaborators

University of Milan

Investigators

Principal Investigator: pietro randelli, prof, University of Milan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pietro Randelli, MD, Professor, University of Milan

ClinicalTrials.gov Identifier:

NCT04905394

Other Study ID Numbers:

SubCond

First Posted:

May 27, 2021

Last Update Posted:

May 27, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Edema

Study Results

No Results Posted as of May 27, 2021