Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
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|ClinicalTrials.gov Identifier: NCT03921489|
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Edema||Procedure: Subchondroplasty||Not Applicable|
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 is aimed 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. Patient 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 VAS scores AOFAS at 3 months, 6 months, 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 OR 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2021|
Experimental: Subchondroplasty in treating bone marrow edema
These patients will have calcium phosphate mineral compound injected into the bone marrow lesions.
Calcium phosphate mineral compound injected into the bone marrow lesions
- Visual Analog Scale for pain [ Time Frame: 0-12 months ]Best 0-10 worst - Continuous scale to measure current pain level
- Subchondroplasty Patient Satisfaction Survey [ Time Frame: 0-12 months ]Worst 0-5 best. 5-item scale to measure patient satisfaction after subchondroplasty procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921489
|Contact: Ellianne Nasser, MD||570-703-7300||EMNASSER@geisinger.edu|
|Contact: Jennifer Harding, MPAfirstname.lastname@example.org|
|Principal Investigator:||Ellianne Nasser, MD||Geisinger Clinic|