Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Marrow Edema
• Intervention / Treatment: Procedure: Subchondroplasty

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: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Ellianne Nasser, MD; Phone Number: 570-703-7300; Email: EMNASSER@geisinger.edu

Study Locations

• United States
  • Pennsylvania
    • Scranton, Pennsylvania, United States, 18510
      • Recruiting
      • Geisinger Community Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with bone marrow edema diagnosed on MRI who elect to receive subchondroplasty procedure

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

Number of groups / cohorts

1

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.	Procedure: Subchondroplasty; Calcium phosphate mineral compound injected into the bone marrow lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for pain	Best 0-10 worst - Continuous scale to measure current pain level	0-12 months
Subchondroplasty Patient Satisfaction Survey	Worst 0-5 best. 5-item scale to measure patient satisfaction after subchondroplasty procedure	0-12 months
The American Orthopedic Foot and Ankle Score (AOFAS)	Worst 0-100 best	0-12 months

Collaborators and Investigators

• Sponsor: Ellianne M. Nasser
• Investigators: Principal Investigator: Ellianne Nasser, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: bone marrow edema; subchondroplasty; foot and ankle
• Additional Relevant MeSH Terms: Edema
• Other Study ID Numbers: 2019-0221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No