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Completed

NCT Number: NCT04905394

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

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.

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Key information

Conditions

Bone Marrow Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaetano Pini hospital

Milan, Lombardy, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Pain reduction

    Time frame: 6 months

    Pain reduction of 4 points in numeric rating score

Secondary outcomes

  1. Radiological evaluation

    Time frame: 6 months

    Evaluation of osteoarthritis progression in the knee on x-rays according to Kellgren&Lawrence classification

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
May 27, 2021
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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