What this trial measures

• Change from Baseline in Intervertebral Disc Hydration at 3 MonthsBaseline 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 YearBaseline 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 YearsBaseline 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 MonthsFrom 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 YearFrom 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 YearsFrom 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 MonthsFrom 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 YearFrom 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 YearsFrom 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 MonthsFrom 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 YearFrom 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 YearsFrom 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 MonthsFrom 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 YearFrom 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 YearsFrom 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 MonthsFrom 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 YearFrom 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 YearsFrom 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.