Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
NCT ID: NCT03921489
Last Updated: 2025-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2021-06-04
2024-12-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Subchondroplasty in treating bone marrow edema
These patients will have calcium phosphate mineral compound injected into the bone marrow lesions.
Subchondroplasty
Calcium phosphate mineral compound injected into the bone marrow lesions
Interventions
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Subchondroplasty
Calcium phosphate mineral compound injected into the bone marrow lesions
Eligibility Criteria
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Inclusion Criteria
* Pain in the foot and ankle due to the presence of bone marrow edema
* Failed 3 months of conservative treatment
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ellianne M. Nasser
OTHER
Responsible Party
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Ellianne M. Nasser
Staff Physician
Principal Investigators
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Ellianne Nasser, MD
Role: PRINCIPAL_INVESTIGATOR
Geisinger Clinic
Locations
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Geisinger Community Medical Center
Scranton, Pennsylvania, United States
Countries
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Other Identifiers
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2019-0221
Identifier Type: -
Identifier Source: org_study_id
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