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临床试验/NCT03921489
NCT03921489已完成不适用

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

Ellianne M. Nasser1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Visual Analog Scale for pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Visual Analog Scale for pain

时间窗: 0-12 months

Best 0-10 worst - Continuous scale to measure current pain level

Subchondroplasty Patient Satisfaction Survey

时间窗: 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)

时间窗: 0-12 months

Worst 0-100 best

次要结局

未报告次要终点

研究者

发起方
Ellianne M. Nasser
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ellianne M. Nasser

Staff Physician

Geisinger Clinic

研究点 (1)

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