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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04905394

Enrollment

Registered

2021-05-27

Start date

2017-04-01

Completion date

2021-01-30

Last updated

2021-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Edema

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.

Interventions

PROCEDUREsubchondroplasty

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
Pain reduction	6 months	Pain reduction of 4 points in numeric rating score

Secondary

Measure	Time frame	Description
Radiological evaluation	6 months	Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren&Lawrence classification

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026