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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
Sponsor:
Information provided by (Responsible Party):
Ellianne M. Nasser, Geisinger Clinic

Brief Summary:
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. The study's hypothesis is 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.

Condition or disease Intervention/treatment Phase
Bone Marrow Edema Procedure: Subchondroplasty Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Foot Health

Arm Intervention/treatment
Experimental: Subchondroplasty in treating bone marrow edema
These patients will have calcium phosphate mineral compound injected into the bone marrow lesions.
Procedure: Subchondroplasty
Calcium phosphate mineral compound injected into the bone marrow lesions




Primary Outcome Measures :
  1. Visual Analog Scale for pain [ Time Frame: 0-12 months ]
    Best 0-10 worst - Continuous scale to measure current pain level

  2. Subchondroplasty Patient Satisfaction Survey [ Time Frame: 0-12 months ]
    Worst 0-5 best. 5-item scale to measure patient satisfaction after subchondroplasty procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BME diagnosed on MRI
  • Pain to that area
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Ellianne Nasser, MD 570-703-7300 EMNASSER@geisinger.edu
Contact: Jennifer Harding, MPA 570-214-6178 jlharding1@geisinger.edu

Sponsors and Collaborators
Ellianne M. Nasser
Investigators
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Principal Investigator: Ellianne Nasser, MD Geisinger Clinic

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Responsible Party: Ellianne M. Nasser, Staff Physician, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03921489     History of Changes
Other Study ID Numbers: 2019-0221
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ellianne M. Nasser, Geisinger Clinic:
bone marrow edema
subchondroplasty
foot and ankle

Additional relevant MeSH terms:
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Edema
Signs and Symptoms