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

NCT03921489 | Completed

• 1 other identifier: 2019-0221
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Edema

Keywords

bone marrow edema; subchondroplasty; foot and ankle

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Subchondroplasty in treating bone marrow edema

These patients will have calcium phosphate mineral compound injected into the bone marrow lesions.

Procedure: Subchondroplasty

Interventions

Subchondroplasty PROCEDURE

Calcium phosphate mineral compound injected into the bone marrow lesions

Subchondroplasty in treating bone marrow edema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ellianne M. Nasser: lead

Study Sites (1)

Geisinger Community Medical Center

Scranton, Pennsylvania, 18510, United States

Location

Study Officials

• Ellianne Nasser, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: June 4, 2021
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: May 4, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)