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

NCT ID: NCT04905394

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-01-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with subchondroplasty for bone edema in the knee

Patients treated with subchondroplasty for bone edema of the knee

Group Type: EXPERIMENTAL

subchondroplasty

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Pietro Randelli, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

pietro randelli, prof

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Locations

Gaetano Pini hospital

Milan, Lombardy, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 37213661 (View on PubMed)

Other Identifiers

SubCond

Identifier Type: -

Identifier Source: org_study_id