Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03921489 |
| Other study ID # |
2019-0221 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 4, 2021 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Geisinger Clinic |
| Contact |
Ellianne Nasser, MD |
| Phone |
570-703-7300 |
| Email |
EMNASSER[@]geisinger.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
