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Completed

NCT Number: NCT03921489

Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle

The subchondroplasty procedure has been used to treat bone marrow edema mostly located in the periarticular region of the knee. In the past few years, it has expanded its use in the foot and ankle. There has, however, been very minimal research documented on its utilization in that area. This study aims to prospectively evaluate the course of treatment and outcomes of painful bone marrow lesions in these associated podiatric circumstances using subchondroplasty. It is hypothesized that use of calcium phosphate bone substitute in the foot and ankle to treat bone marrow edema will have more favorable short and long-term outcomes than joint destructive and joint sparing procedures more commonly performed for treatment in the past.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Geisinger Community Medical Center

Scranton, Pennsylvania, 18510, United States

About this study

The subchondroplasty procedure has been used to treat bone marrow edema mostly located in the periarticular region of the knee. In the past few years, it has expanded its use in the foot and ankle. There has, however, been very minimal research documented on its utilization in that area. Bone marrow edema arises from altered stresses on bones due to osteoarthritis, biomechanical abnormalities, coalitions, infection, and trauma. This study aims to prospectively evaluate the course of treatment and outcomes of painful bone marrow lesions in these associated podiatric circumstances using subchondroplasty. This should, therefore, expose this modality as a viable treatment option for bone marrow edema.

Patients will be evaluated in the office/clinic setting with a positive diagnosis of bone marrow edema confirmed via MRI. They must have failed 3 months of conservative treatment measures including, but not limited to, orthotic modifications, taping, immobilization or offloading, and anti-inflammatories. The study population includes individuals over the age of 18 with no significant comorbidities or previous foot and ankle surgical interventions. These patients will go on to have calcium phosphate mineral compound injected into the bone marrow lesions. We will track the progression of their symptoms and evaluate via Visual Analog Scale (VAS) pain score and the American Orthopedic Foot and Ankle Score (AOFAS) at 3-month, 6-month, and 1-year follow-ups.

The subchondroplasty procedure is a viable treatment option for bone marrow edema in the setting of altered pedal biomechanics, gait abnormalities, osteoarthritis, and trauma. It is a minimally invasive procedure that maximizes positive outcomes, allows the patient to be immediately weight bearing following surgery, and has short operating room times. This surgical procedure is a new and innovative technique introduced to the podiatric field that will allow the surgeon to intervene at an earlier stage in efforts to alleviate symptoms. It is hypothesized that use of calcium phosphate bone substitute in the foot and ankle to treat bone marrow edema will have more favorable short and long-term outcomes than joint destructive and joint sparing procedures more commonly performed for treatment in the past.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Bone marrow edema diagnosed on MRI
  • Pain in the foot and ankle due to the presence of bone marrow edema
  • Failed 3 months of conservative treatment

Exclusion criteria

  • Patient <18 years of age
  • Presence of osteomyelitis of poor surgical candidates due to comorbidities such as diabetics with an HbA1c of >8%
  • Patient with previous foot and ankle surgeries that may interfere with future outcomes

Treatment and study plan

subchondroplasty

Procedure

Calcium phosphate mineral compound injected into the bone marrow lesions

Primary outcomes

  1. Visual Analog Scale for pain

    Time frame: 0-12 months

    Best 0-10 worst - Continuous scale to measure current pain level

  2. Subchondroplasty Patient Satisfaction Survey

    Time frame: 0-12 months

    Worst 0-5 best. 5-item scale to measure patient satisfaction after subchondroplasty procedure

  3. The American Orthopedic Foot and Ankle Score (AOFAS)

    Time frame: 0-12 months

    Worst 0-100 best

Sponsors and collaborators

Lead sponsor

Ellianne M. Nasser

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2019
Registry last updated
May 4, 2025

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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