- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03921489
Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
Study Overview
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ellianne Nasser, MD
- Phone Number: 570-703-7300
- Email: EMNASSER@geisinger.edu
Study Locations
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Pennsylvania
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Scranton, Pennsylvania, United States, 18510
- Recruiting
- Geisinger Community Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subchondroplasty in treating bone marrow edema
These patients will have calcium phosphate mineral compound injected into the bone marrow lesions.
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Calcium phosphate mineral compound injected into the bone marrow lesions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale for pain
Time Frame: 0-12 months
|
Best 0-10 worst - Continuous scale to measure current pain level
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0-12 months
|
Subchondroplasty Patient Satisfaction Survey
Time Frame: 0-12 months
|
Worst 0-5 best.
5-item scale to measure patient satisfaction after subchondroplasty procedure
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0-12 months
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The American Orthopedic Foot and Ankle Score (AOFAS)
Time Frame: 0-12 months
|
Worst 0-100 best
|
0-12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ellianne Nasser, MD, Geisinger Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0221
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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