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.
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
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
Parallel
Bone Marrow Aspirate Concentrate (BMAC)
Other interventionDosage Form: Autologous intradiscal injection Dosage: 1-2 cc's Frequency: Once, during surgery Duration: N/A
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.
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.
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.
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.
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.
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.
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.
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.
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Weill Medical College of Cornell University
Lead sponsor
Aclarion
Collaborator
