Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Change in Pain scores measured with the Visual Analog Scale (VAS).
研究概览
简要总结
The primary objective of this study is to determine whether the Hyperbaric Oxygen Therapy (HBOT) conducted under the Marx Protocol improves pain outcomes when combined with core decompression with autologous bone marrow aspirate concentrate to treat patients with femoral head avascular necrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Diagnosed with femoral head avascular necrosis
- •Enrolled into Yale Avascular Necrosis Program
- •Avascular necrosis lesion is classified as ARCO I or ARCO II by Investigator
- •Surgical Candidate for Core Decompression using 3D image guidance with bone marrow aspirate concentrate
排除标准
- •Hip has already collapsed due to severe avascular necrosis (ARCO III or ARCO IV)
- •Medical comorbidities that prevent them from being a surgical candidate (example: obesity)
- •Absolute contraindications to HBOT, including severe decompensated cardiac failure or lung disease putting them at high risk for pneumothorax
- •Does not sign Informed Consent Form
研究组 & 干预措施
HBOT outside Yale
The participant is having HBOT sessions at a different location (outside of the Yale New Haven Health system). These treatments will be overseen by the outside facility's HBOT Director and completed according to the Marx protocol . The patient is responsible for picking a site, setting up their intake appointments, and going to the treatments. The patient is also responsible for providing the HBOT site Director with our protocol as well as returning a completed form that indicates that the proper protocol was used.
干预措施: Hyperbaric Oxygen Therapy (Device)
Hyperbaric Oxygen Therapy- Reduced Marx Protocol
20 treatments before surgery and 10 treatments after surgery
干预措施: Hyperbaric Oxygen Therapy (Device)
Control
No hyperbaric oxygen therapy
Hyperbaric Oxygen Therapy- Full Marx Protocol
30 treatments before surgery, and 10 treatments after surgery
干预措施: Hyperbaric Oxygen Therapy (Device)
结局指标
主要结局
Change in Pain scores measured with the Visual Analog Scale (VAS).
时间窗: baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Participants will be asked to mark a point on a 100 mm horizontal line that represents the intensity of their pain. This line has two endpoints: 0: No pain and 10: Worst possible pain imaginable. The distance from the "0" to the mark is measured in millimeters with the resulting number (0-10) being the VAS pain score.
次要结局
- Change in Pain interference PROMIS questionnaire scores(baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years)
- Change in Physical function/mobility PROMIS questionnaire scores(baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years)
- Change in Oxford Hip Scores (OHS)(baseline, after every 5 treatments of HBOT treatment, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years)
- Change in ARCO classification(baseline, 6 weeks, 4.5 months, 9 months, 1 year, 2 years, 3 years, 4 years, and 5 years)