Bone Marrow Aspirate Concentrate Injection With MRI's - A Prospective Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change from Baseline in Intervertebral Disc Hydration at 3 Months
研究概览
简要总结
The goal of this clinical trial is to find out whether adding a bone-marrow aspirate concentrate (BMAC) injection during surgery can improve recovery in adults undergoing lumbar microdiscectomy for a lumbar disc herniation.
The main questions it aims to answer are:
- Does the BMAC injection lead to better disc tissue health after surgery (as seen on MRI scans)?
- Does the BMAC injection lead to greater improvement in pain and disability compared to surgery alone?
Participants will be adults aged 18 and older who are scheduled for lumbar microdiscectomy surgery.
Researchers will compare one group of participants receiving the standard-of-care surgery plus the BMAC injection with another group receiving the same surgery without the injection to see if the injection offers added benefit.
Participants will:
- Have surgery (microdiscectomy) with or without the injection.
- Complete pain and disability questionnaires at several times over 2 years.
- Undergo MRI scans at baseline and follow-up to assess disc structure and tissue health.
- Provide samples of leftover disc or bone-marrow tissue (as applicable) from surgery for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Male or female patients ≥ 18 years of age
- •Clinically and/or radiographically (MRI) confirmed diagnosis of degenerative disc disease of the lumbar spine, lumbar disc herniation, and indication for lumbar microdiscectomy surgery
- •Unresponsive to conservative/non-operative treatment for >3 months
- •Psychosocial, mental and physical ability to understand and to adhere to this protocol, especially adhering to the visit schedule follow-ups and observe the treatment plan
排除标准
- •Prisoners
- •Individuals who are not yet adults (infants, children, teenagers)
- •Individuals who are not able to clearly understand English
- •Adults with diminished capacity to consent
- •Major cognitive impairment causing to inability to understand and provide informed consent
- •Active malignancy
- •Active chronic or acute infection
- •Autoimmune disorder that impacts the lumbar spine (ankylosing spondylitis, lupus e.g.)
- •Bone marrow-derived or non-bone marrow-derived cancer
- •Low platelet count or clotting disorders
- •Prior surgery at the level to be treated or the adjacent level
研究组 & 干预措施
BMAC Group
Administration of one 1-2cc intradiscal Bone Marrow Aspirate Concentrate (BMAC) injection during lumbar microdiscectomy surgery.
干预措施: Bone Marrow Aspirate Concentrate (BMAC) (Other)
Control Group
Standard of care lumbar microdiscectomy surgery without the BMAC injection.
结局指标
主要结局
Change from Baseline in Intervertebral Disc Hydration at 3 Months
时间窗: Baseline and 3 Months post-operation
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Change from Baseline in Intervertebral Disc Hydration at 1 Year
时间窗: Baseline and 1 year post-operation
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Change from Baseline in Intervertebral Disc Hydration at 2 Years
时间窗: Baseline and 2 years post-operation
MRI T2 mapping and T2 relaxation time are advanced imaging techniques that help assess the hydration status of intervertebral discs. These two metrics will be combined as one data point. T2 relaxation time measures the decay of the MRI signal, which is influenced by the water content in the disc. Higher T2 values indicate better hydration, while lower T2 values suggest dehydration and degeneration. T2 mapping provides a detailed, quantitative assessment of the disc's water content, allowing for early detection of degenerative changes before they become visible on standard MRI images. This information is crucial for diagnosing the extent of disc degeneration, planning surgical interventions, and monitoring the effectiveness of treatments aimed at restoring disc health.
Change from Baseline in Proteoglycan Content at 3 Months
时间窗: From enrollment to 3 Months post-operation
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Change from Baseline in Proteoglycan Content at 1 Year
时间窗: From enrollment to 1 year post-operation
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Change from Baseline in Proteoglycan Content at 2 Years
时间窗: From enrollment to 2 years post-operation
MRI T1 rho mapping and T1 rho relaxation time are advanced imaging techniques that provide insights into the biochemical composition of intervertebral discs, particularly the proteoglycan content. T1 rho relaxation time measures the decay of the MRI signal in the presence of a spin-lock pulse, which is sensitive to interactions between water molecules and macromolecules like proteoglycans. These two metrics will be combined as one data point. Higher T1 rho values indicate higher proteoglycan content and better disc hydration, while lower values suggest degeneration and reduced proteoglycan levels. T1 rho mapping offers a detailed, quantitative assessment of these biochemical changes, allowing for early detection of disc degeneration and aiding in the evaluation of treatment efficacy.
Change from Baseline in Disc Height Index at 3 Months
时间窗: From enrollment to 3 months post-operation
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Change from Baseline in Disc Height Index at 1 Year
时间窗: From enrollment to 1 year post-operation
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Change from Baseline in Disc Height Index at 2 Years
时间窗: From enrollment to 2 years post-operation
Assessed via MRI, the Disc Height Index (DHI) is a measurement used in spine surgery to assess the height of an intervertebral disc. It is calculated by dividing the height of the disc at the mid-vertebral line by the height of the superior vertebral body. This index helps in evaluating the degree of disc degeneration and is often used to monitor changes before and after surgical interventions.
Change from Baseline in Pfirrmann Grade at 3 Months
时间窗: From enrollment to 3 months post-operation
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Change from Baseline in Pfirrmann Grade at 1 Year
时间窗: From enrollment to 1 year post-operation
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Change from Baseline in Pfirrmann Grade at 2 Years
时间窗: From enrollment to 2 years post-operation
Assessed via MRI, Pfirrmann grading is a radiological classification used to assess the severity of lumbar intervertebral disc degeneration. It categorizes disc degeneration into five grades based on specific criteria related to the appearance of the discs: Grade I: Normal disc with high signal intensity and well-defined nucleus and annulus. Grade II: Slightly degenerated disc with a normal height but a lower signal intensity in the nucleus. Grade III: Moderate degeneration with a loss of disc height and a more pronounced decrease in signal intensity. Grade IV: Severe degeneration with significant loss of disc height and a very low signal intensity. Grade V: End-stage degeneration with a collapsed disc and no visible nucleus
Change from Baseline in Nucleus Pulposus Size at 3 Months
时间窗: From enrollment to 3 months post-operation
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Change from Baseline in Nucleus Pulposus Size at 1 Year
时间窗: From enrollment to 1 year post-operation
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Change from Baseline in Nucleus Pulposus Size at 2 Years
时间窗: From enrollment to 2 years post-operation
The Nucleus Pulposus is the soft, gel-like center of an intervertebral disc, surrounded by the tougher annulus fibrosus. It plays a crucial role in absorbing shock and allowing flexibility in the spine. Assessed via MRI, the size and condition of the nucleus pulposus are indicators of disc health. A healthy nucleus pulposus is typically well-hydrated and maintains disc height, while a degenerated nucleus pulposus may shrink and lose its cushioning ability.
Change from Baseline in NOCISCORE at 3 Months
时间窗: From enrollment to 3 months post-operation
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
Change from Baseline in NOCISCORE at 1 Year
时间窗: From enrollment to 1 year post-operation
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
Change from Baseline in NOCISCORE at 2 Years
时间窗: From enrollment to 2 years post-operation
Assessed via MRI, decreases in pain biomarkers within the intervertebral disc will be measured using Magnetic Resonance Spectroscopy (MRS). MRS is non-invasive. The data is analyzed and summarized in a NOCIGRAM report, which provides an objective analysis of the pain biomarkers observed during a preoperative MRI scan. The NOCISCORE measures six biomarker ratios associated with pain generation for each disc. The scores for each disc level are categorized into NOCI+, Mild, and NOCI-, from most 'painful' to 'least painful' levels.
次要结局
- Change from Baseline in Patient Reported Pain at 3 Months(From enrollment to 3 Months post-operation)
- Change from Baseline in Patient Reported Pain at 6 Months(From enrollment to 6 Months post-operation)
- Change from Baseline in Patient Reported Pain at 1 Year(From enrollment to 1 Year post-operation)
- Change from Baseline in Patient Reported Pain at 2 Years(From enrollment to 2 years post-operation)
- Change from Baseline in Patient Reported Disability at 3 Months(From enrollment to 3 Months post-operation)
- Change from Baseline in Patient Reported Disability at 6 Months(From enrollment to 6 Months post-operation)
- Change from Baseline in Patient Reported Disability at 1 Year(From enrollment to 1 year post-operation)
- Change from Baseline in Patient Reported Disability at 2 Years(From enrollment to 2 years post-operation)
- Change from Baseline in SI-Score at 3 Months(From enrollment to 3 months post-operation)
- Change from Baseline in SI-Score at 1 Year(From enrollment to 1 year post-operation)
- Change from Baseline in SI-Score at 2 Years(From enrollment to 2 years post-operation)