Clinical trial NCT03921489: Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
Official title: Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Edema
Keywords: bone marrow edema
subchondroplasty
foot and ankle
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bone marrow edema diagnosed on MRI who elect to receive subchondroplasty procedure

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale for pain
timeFrame: 0-12 months
measure: Subchondroplasty Patient Satisfaction Survey
timeFrame: 0-12 months
measure: The American Orthopedic Foot and Ankle Score (AOFAS)
timeFrame: 0-12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scranton
country: United States
facility: Geisinger Community Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Ellianne Nasser, MD
role: PRINCIPAL_INVESTIGATOR
References: