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

NCT ID: NCT03921489

Last Updated: 2025-05-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-04

Study Completion Date

2024-12-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bone Marrow Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ellianne M. Nasser

OTHER

Sponsor Role lead

Responsible Party

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Ellianne M. Nasser

Staff Physician

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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2019-0221

Identifier Type: -

Identifier Source: org_study_id

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