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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Dosage Form: Autologous intradiscal injection Dosage: 1-2 cc's Frequency: Once, during surgery Duration: N/A
NewYork-Presbyterian/Weill Cornell Medical Center
Manhattan, New York, United States
Change from Baseline in Intervertebral Disc Hydration at 3 Months
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.
Time frame: Baseline and 3 Months post-operation
Change from Baseline in Intervertebral Disc Hydration at 1 Year
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.
Time frame: Baseline and 1 year post-operation
Change from Baseline in Intervertebral Disc Hydration at 2 Years
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.
Time frame: Baseline and 2 years post-operation
Change from Baseline in Proteoglycan Content at 3 Months
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.
Time frame: From enrollment to 3 Months post-operation
Change from Baseline in Proteoglycan Content at 1 Year
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.
Time frame: From enrollment to 1 year post-operation
Change from Baseline in Proteoglycan Content at 2 Years
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.
Time frame: From enrollment to 2 years post-operation
Change from Baseline in Disc Height Index at 3 Months
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.
Time frame: From enrollment to 3 months post-operation
Change from Baseline in Disc Height Index at 1 Year
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.
Time frame: From enrollment to 1 year post-operation
Change from Baseline in Disc Height Index at 2 Years
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.
Time frame: From enrollment to 2 years post-operation
Change from Baseline in Pfirrmann Grade at 3 Months
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
Time frame: From enrollment to 3 months post-operation
Change from Baseline in Pfirrmann Grade at 1 Year
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
Time frame: From enrollment to 1 year post-operation
Change from Baseline in Pfirrmann Grade at 2 Years
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
Time frame: From enrollment to 2 years post-operation
Change from Baseline in Nucleus Pulposus Size at 3 Months
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.
Time frame: From enrollment to 3 months post-operation
Change from Baseline in Nucleus Pulposus Size at 1 Year
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.
Time frame: From enrollment to 1 year post-operation
Change from Baseline in Nucleus Pulposus Size at 2 Years
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.
Time frame: From enrollment to 2 years post-operation
Change from Baseline in NOCISCORE at 3 Months
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.
Time frame: From enrollment to 3 months post-operation
Change from Baseline in NOCISCORE at 1 Year
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.
Time frame: From enrollment to 1 year post-operation
Change from Baseline in NOCISCORE at 2 Years
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.
Time frame: From enrollment to 2 years post-operation
Change from Baseline in Patient Reported Pain at 3 Months
The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Time frame: From enrollment to 3 Months post-operation
Change from Baseline in Patient Reported Pain at 6 Months
The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Time frame: From enrollment to 6 Months post-operation
Change from Baseline in Patient Reported Pain at 1 Year
The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Time frame: From enrollment to 1 Year post-operation
Change from Baseline in Patient Reported Pain at 2 Years
The Numeric Rating Scale (NRS) is one of the most commonly used pain scales in medicine. It can be administered verbally or self-administered on paper. Zero is equivalent to no pain and 10 indicates the worst possible pain.
Time frame: From enrollment to 2 years post-operation
Change from Baseline in Patient Reported Disability at 3 Months
The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).
Time frame: From enrollment to 3 Months post-operation
Change from Baseline in Patient Reported Disability at 6 Months
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The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).
Time frame: From enrollment to 6 Months post-operation
Change from Baseline in Patient Reported Disability at 1 Year
The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).
Time frame: From enrollment to 1 year post-operation
Change from Baseline in Patient Reported Disability at 2 Years
The Oswestry Disability Index (ODI) is a self-administered questionnaire divided into ten sections designed to assess limitations in various aspects of daily living activities. Each section is scored from 0 to 5, where 0 indicates no disability and 5 indicates maximum disability. The total score is calculated as a percentage ranging from 0% (no disability) to 100% (maximum disability).
Time frame: From enrollment to 2 years post-operation
Change from Baseline in SI-Score at 3 Months
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 SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).
Time frame: From enrollment to 3 months post-operation
Change from Baseline in SI-Score at 1 Year
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 SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).
Time frame: From enrollment to 1 year post-operation
Change from Baseline in SI-Score at 2 Years
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 SI-Score (Structural Integrity Score) reflects the relative amounts of proteoglycan between discs as an indication of relative structural integrity between the discs on a scale from 0 to 1. Higher SI scores reflect higher relative values as compared between discs in the patient and do not necessarily reflect high structural integrity. A low SI score, corresponding to a lower structural integrity, is associated with more advanced degeneration (relative between discs).
Time frame: From enrollment to 2 years post-operation