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

NCT04905394 | Completed

• 1 other identifier: SubCond
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Edema

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  Pain reduction of 4 points in numeric rating score

  6 months

Secondary Outcomes (1)

• Radiological evaluation

  6 months

Study Arms (1)

Treatment with subchondroplasty for bone edema in the knee

EXPERIMENTAL

Patients treated with subchondroplasty for bone edema of the knee

Procedure: subchondroplasty

Interventions

subchondroplasty PROCEDURE

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.

Treatment with subchondroplasty for bone edema in the knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Gaetano Pini hospital

Milan, Lombardy, 20122, Italy

Location

Related Publications (1)

• Randelli P, Compagnoni R, Ferrua P, Ricci M, La Verde L, Mekky AF, De Silvestri A, Menon A. Efficacy of Subchondroplasty in the Treatment of Pain Associated With Bone Marrow Lesions in the Osteoarthritic Knee. Orthop J Sports Med. 2023 May 16;11(5):23259671231163528. doi: 10.1177/23259671231163528. eCollection 2023 May.

  PMID: 37213661 DERIVED

Study Officials

• pietro randelli, prof

  University of Milan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 27, 2021
• Study Start: April 1, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)