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Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle
| Condition or disease | Intervention/treatment |
|---|---|
| Bone Marrow Edema | Procedure: Subchondroplasty |
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 |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle |
| Estimated Study Start Date : | March 2021 |
| Estimated Primary Completion Date : | February 2023 |
| Estimated Study Completion Date : | February 2023 |
| 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
|
- 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
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
| Contact: Ellianne Nasser, MD | 570-703-7300 | EMNASSER@geisinger.edu | |
| Contact: Jennifer Harding, MPA | 570-214-6178 | jlharding1@geisinger.edu |
| Principal Investigator: | Ellianne Nasser, MD | Geisinger Clinic |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 17, 2019 | ||||||||
| First Posted Date | April 19, 2019 | ||||||||
| Last Update Posted Date | February 23, 2021 | ||||||||
| Estimated Study Start Date | March 2021 | ||||||||
| Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures |
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| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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 | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients with bone marrow edema diagnosed on MRI who elect to receive subchondroplasty procedure | ||||||||
| Condition | Bone Marrow Edema | ||||||||
| Intervention | Procedure: Subchondroplasty
Calcium phosphate mineral compound injected into the bone marrow lesions
|
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| Study Groups/Cohorts | Subchondroplasty in treating bone marrow edema
These patients will have calcium phosphate mineral compound injected into the bone marrow lesions.
Intervention: Procedure: Subchondroplasty
|
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
20 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | February 2023 | ||||||||
| Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03921489 | ||||||||
| Other Study ID Numbers | 2019-0221 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Ellianne M. Nasser, Geisinger Clinic | ||||||||
| Study Sponsor | Ellianne M. Nasser | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Geisinger Clinic | ||||||||
| Verification Date | November 2020 | ||||||||