Breakthrough Clinical Results
Drs. Lanman and Ament performed the first known combined implantation of the MOTUS total joint replacement device and the TOPS™ System at adjacent lumbar levels (L5-S1 and L4-5) in a patient with severe facet disease. This innovative approach, combining a posterior total joint replacement with a dynamic stabilization system, addresses multilevel facet pathology and offers a potential solution for patients unsuitable for traditional disc replacement alone. The procedure demonstrates a significant advancement in motion-preserving spine surgery, showcasing the combined capabilities of the MOTUS device and TOPS™ System in restoring mobility and stability in the lower lumbar spine. The MOTUS device is currently under investigation in a pivotal clinical trial and has received Breakthrough Device Designation from the FDA.
Key Highlights
- First-ever combined implantation of MOTUS and TOPS™ systems at adjacent lumbar levels.
- Successful treatment of severe facet disease in a young patient.
- Innovative approach combining posterior total joint replacement and dynamic stabilization.
- MOTUS device has received Breakthrough Device Designation from the FDA.
Incidence and Prevalence
Global Incidence of Lumbar Degenerative Spine Disease (DSD) with Low Back Pain (LBP):
According to a 2019 study, approximately 266 million individuals (3.63%) worldwide experience Lumbar Degenerative Spine Disease (DSD) accompanied by Low Back Pain (LBP) each year. This figure represents the incidence of DSD with neurosurgical relevance, meaning the DSD is symptomatic and causing LBP.
Regional Variations:
The incidence of DSD with LBP varies across World Health Organization regions:
- Europe: Highest estimated incidence at 5.7%.
- Africa: Lowest estimated incidence at 2.4%.
Income-Based Disparities:
The study also highlighted a significant disparity in the number of cases based on World Bank income groups:
- Low- and middle-income countries: Account for four times the number of cases compared to high-income countries. This difference is primarily attributed to larger population sizes in these income groups.
Specific Lumbar DSD Conditions:
The study provided annual global incidence estimates for specific lumbar DSD conditions:
- Spondylolisthesis: 39 million individuals (0.53%).
- Symptomatic disc degeneration: 403 million individuals (5.5%).
- Spinal stenosis: 103 million individuals (1.41%).
Data Quality Considerations:
It's important to note that data quality is generally higher in high-income countries. This means that the quantification of DSD incidence in low- and middle-income countries might be less complete due to limitations in data collection and reporting.
Prevalence of Diagnosed Spinal Degenerative Disease:
Another study, published in 2020, using Medicare insurance claim data, found the overall prevalence of diagnosed spinal degenerative disease to be 27.3%. This figure likely underestimates the true prevalence, as asymptomatic individuals may not seek medical attention and therefore remain undiagnosed.
Prevalence of Lumbar DSD (Clinical and Radiological):
A 2019 systematic review provided pooled prevalence estimates for lumbar spinal stenosis (LSS), a common form of lumbar DSD. The estimates varied depending on the diagnostic criteria and care setting:
Clinical Diagnosis:
- General population: 11% (95% CI 4-18%).
- Primary care: 25% (95% CI 19-32%).
- Secondary care: 29% (95% CI 22-36%).
- Mixed primary and secondary care: 39% (95% CI 39-39%).
Radiological Diagnosis:
- Asymptomatic population: 11% (95% CI 5-18%).
- General population: 38% (95% CI -10 to 85%).
- Primary care: 15% (95% CI 13-18%).
- Secondary care: 32% (95% CI 22-41%).
- Mixed primary and secondary care: 21% (95% CI 16-26%).
The review authors cautioned that the included studies had a high risk of bias, so these estimates should be interpreted with caution.
Prevalence of Lumbar Disc Degeneration in Young Adults:
A 2019 retrospective cohort study of 730 symptomatic young adults (aged 20-30 years) found that 58.6% had MRI evidence of lumbar disc degeneration (Pfirrmann grades III, IV, or V).
In summary, while the incidence of symptomatic lumbar DSD (with LBP) is estimated around 3.63% annually, the prevalence of diagnosed spinal degenerative disease is much higher, estimated at 27.3%. The prevalence of specific types of lumbar DSD, such as LSS, varies depending on diagnostic criteria and care setting. It's crucial to consider data quality and potential biases when interpreting these estimates.
Risk Factors and Comorbidities
Lumbar spinal degeneration (LSD), also known as degenerative disc disease, is a common condition characterized by the breakdown of the intervertebral discs in the lower back. It's a multifactorial condition, meaning several risk factors and comorbidities contribute to its development. While pinpointing the top 3 is difficult due to varying studies and individual patient profiles, the following consistently emerge as prominent factors:
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Aging: This is the most significant and unavoidable risk factor. With age, discs lose water content, become less flexible, and more prone to tears and herniation. One study found that age >50 years had an odds ratio (OR) of 1.7/year for disc degeneration and herniation. Another study showed that progression rates for anterior osteophytes and disc space narrowing were 4% and 3% per annum, respectively, with age being a strong predictor. Several other studies also highlighted increasing age as a primary risk factor for various spinal degenerative conditions, including LSD, stenosis, and deformity. Age-related changes like reduced bone density mass and more severe spinal degeneration further contribute to the risk.
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Genetic Predisposition: Family history plays a crucial role. Individuals with a family history of LSD are significantly more likely to develop the condition themselves. One study reported an OR of 4.0 for individuals with a family disposition. Twin studies have shown that heredity accounts for up to 74% of the variance in disc degeneration. Specific gene forms associated with disc degeneration have also been identified, further confirming the genetic influence. While genetic factors are non-modifiable, understanding their contribution helps in early detection and personalized management.
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Biomechanical Stress and Lifestyle Factors: This encompasses a range of factors that place stress on the spine.
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Obesity (elevated BMI): Increased weight puts extra strain on the discs, accelerating their degeneration. One study found an OR of 2.77 for elevated BMI. Other studies also identified higher BMI as a risk factor for various complications, including ASD and cage subsidence after spinal surgery.
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Smoking: Reduces blood supply to the discs, hindering their ability to repair themselves. One study reported an OR of 3.8 for smoking. Other studies also highlighted smoking as a major risk factor for LSD and other spinal pathologies, leading to increased pain, delayed recovery, and greater need for surgery.
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Occupational factors: Certain occupations involving heavy lifting, bending, twisting, or prolonged sitting can contribute to LSD. One study found night shift work to be a significant predictor of disc degeneration (OR 23.01). Other studies also identified occupational and mechanical influences as major risk factors, although their impact may be less than genetic factors.
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Physical inactivity: Lack of exercise weakens the muscles supporting the spine, increasing the load on the discs. One study found that lack of sports activities was a significant predictor for disc degeneration (OR 2.71). Other studies also highlighted physical inactivity as a risk factor, especially in older adults.
Comorbidities that are frequently associated with LSD and can exacerbate its progression include:
- Diabetes Mellitus: One study found an OR of 6.8 for diabetes. Another study showed that diabetes was associated with a six-fold higher risk of disc degeneration in the upper lumbar spine.
- Hypertension: One study found an OR of 1.25 for hypertension.
- Dyslipidemia: One study found an OR of 1.26 for dyslipidemia.
- Atherosclerosis: One study found an OR of 2.24 for atherosclerosis.
- Arthritis in other joints: One study found an OR of 3.1 for arthritis in other joints.
It's important to note that these are not the only risk factors and comorbidities associated with LSD. Others, such as previous back injuries, female gender, and certain spinal anatomical variations, can also play a role. A comprehensive assessment considering individual patient characteristics is crucial for accurate diagnosis and personalized management of LSD.
Drug used in other indications
The provided text focuses on the TOPS™ System for lumbar spinal stenosis and degenerative spondylolisthesis, and does not mention trials for other indications. It also mentions a 2D imaged-based motion capture system called PEAK Motus used to study the effects of aging on spinal range of motion, but this is not an implant or surgical device like the TOPS™ System. Therefore, the question about other indications for the TOPS™ System cannot be answered from the given text.
Regarding the PEAK Motus system, the provided text describes its use in a study of age-related changes in spinal range of motion. The intervention models for this study involved:
- Comparison between age groups: Healthy young adults were compared to healthy older adults.
- Specific movements: Participants performed flexion and extension movements in the cervical, thoracic, and lumbar spine.
- Alternative movement tests: A "cat-stretch" movement in the all-fours position was used to assess thoracic extension, and a "toe-touch" movement in standing was used to assess lumbar flexion. These alternative movements were investigated to determine if they allowed a greater range of motion compared to standard flexion/extension tests.
The study used a revised model of skin marker placement with the 2D PEAK Motus system. Data was collected via video recordings of the participants performing the movements. The primary outcome measure was the range of motion in each spinal region. The study found that older adults had significantly decreased flexion/extension ranges in all spinal regions compared to younger adults. The alternative movement tests (cat-stretch and toe-touch) did allow for greater range of motion in the thoracic and lumbar spine, respectively.
It's important to note that this study used the Motus system as a measurement tool to assess range of motion, not as a therapeutic intervention. The text does not describe any clinical trials involving the Motus system as a treatment for any medical condition.