Bone Marrow EdemaNCT03921489
Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
An observational study of Bone Marrow Edema, run by Ellianne M. Nasser at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Marrow Edema
- What is being tested?
- Subchondroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2021to 19 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bone marrow edema diagnosed on MRI who elect to receive subchondroplasty procedure
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Community Medical Center
Scranton, Pennsylvania, 18510
About this study
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.
Read the 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.
- Conditions
- Bone Marrow Edema
- Being tested
- Subchondroplasty
- Keywords
- bone marrow edema, subchondroplasty, foot and ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SubchondroplastyProcedure or surgery
Calcium phosphate mineral compound injected into the bone marrow lesions
| Study group | Role | What they receive |
|---|---|---|
| Subchondroplasty in treating bone marrow edema | These patients will have calcium phosphate mineral compound injected into the bone marrow lesions. Receives: Procedure: Subchondroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale for pain
Best 0-10 worst - Continuous scale to measure current pain level
Measured: 0-12 months
Subchondroplasty Patient Satisfaction Survey
Worst 0-5 best. 5-item scale to measure patient satisfaction after subchondroplasty procedure
Measured: 0-12 months
The American Orthopedic Foot and Ankle Score (AOFAS)
Worst 0-100 best
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start4 Jun 2021
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Marrow EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellianne M. Nasser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ellianne M. Nasser, Geisinger Clinic
- Investigators
- Ellianne Nasser, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921489
- Sponsor's protocol ID
- 2019-0221
- Status last verified
- Sep 2024
- First submitted
- 17 Apr 2019
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
- ClinicalTrials.gov ID
- NCT03921489
- Acronym / sponsor ID
- 2019-0221
- Conditions
- Bone Marrow Edema
- Keywords
- bone marrow edema, subchondroplasty, foot and ankle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ellianne M. NasserUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subchondroplasty in treating bone marrow edema | – | Procedure: SubchondroplastyThese patients will have calcium phosphate mineral compound injected into the bone marrow lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bone marrow edema diagnosed on MRI who elect to receive subchondroplasty procedure
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SubchondroplastyCalcium phosphate mineral compound injected into the bone marrow lesions | Procedure or surgery | Subchondroplasty in treating bone marrow edema |
Primary outcome
Visual Analog Scale for pain
Time frame: 0-12 months
Best 0-10 worst - Continuous scale to measure current pain level
Subchondroplasty Patient Satisfaction Survey
Time frame: 0-12 months
Worst 0-5 best. 5-item scale to measure patient satisfaction after subchondroplasty procedure
The American Orthopedic Foot and Ankle Score (AOFAS)
Time frame: 0-12 months
Worst 0-100 best
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
Related trials for Bone Marrow Edema
Recruiting
Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis
Knee Arthritis, Osteoarthritis, Bone Marrow Edema of the Knee
Recruiting
Focused Extracorporeal Shockwave Therapy for Knee Arthritis
Bone Marrow Edema, Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellianne Nasser, MD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Marrow Edema, run by Ellianne M. Nasser at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale for pain (time frame: 0-12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.