1. AuDi Trial
For 100 years Surgeons have removed soft dislodged disc during operations for sciatica – it’s time to replace it with a silicone cushion trial.
Problem: The conventional surgical approach for treating a herniated disc in the lumbar region is microdiscectomy, wherein the loose cartilage fragments in the spinal canal are removed or complete clearance of the disc cavity is performed to relieve pressure on the spinal nerves to alleviate pain and/or neurologic deficit. Although this operation results in immediate pain relief, recent data reveals that almost a third of the discectomy patients are not happy with their surgical outcomes at 12-month follow-up. One in five patients will re-herniate and will need another major operation. The reasons for which are
- pain as a result of decreased disc height following removal of soft part of the disc or;
- the residual soft disc material left within the cavity, comes out again (re-herniates) or;
- a combination of disc height loss and re-herniation.
Solution: A shock absorbing new medical device that can replace the lost soft disc fragment can potentially maintain lumbar disc height for patients undergoing a microdiscectomy procedure for Lumbar Disc Herniation (LDH); and therefore, can reduce the need for another major surgery. The investigational device of the AuDi trial (an elastomeric Disc Device) intends to explore this possibility. The new elastomeric disc has been developed on the basis of growing evidence that full or partial soft disc replacement is an effective means of preserving the disc height, thereby preserves the disc form and function patients undergoing routine microdiscectomy.
How can you participate: If you suffer leg pain and your doctor has suggested a single-level microdiscectomy for Sciatica due to symptomatic LDH (Lumbar Disc Herniation), you can contact the Clinical care team or the Clinical Trial Coordinator (02-85667166/102).
2. EMERALD Trial
Establishing relation between microbiome and neck related problems like painful arms, weak lower legs or just neck pain.
Our main objective is to understand the relationship between a patient’s microbiome ie the bugs we live with on and in our body, and the outcome of anterior cervical spine surgery. This study is innovative in the sense that it will be a prospective study, obtaining a sample of the microbiome in a case-controlled series before the procedure takes place and comparing these findings to the clinical and radiological results to find an association between poor outcomes and certain strains of bacteria that may be present in the skin, the mouth or GI tract (stool samples). Also, regular quantification of inflammatory markers will likely shed some light in the inflammatory process that goes on after a surgery and the relationship between this process and the outcome (clinical and radiological) of the procedure. To our knowledge this has never been reported.
3. The MiSO Study
Imagine when your doctor could recommend a diet that would result in greater post-surgery relief?!
What we want to know: How does one’s microbiome affect the surgery outcome?
Background: Spinal surgeries are very commonly performed in chronic back pain and neck pain patients to manage pain arising due to degenerative intervertebral disc. However, in about 10 - 20% of the cases, such surgeries fail to relieve pain symptoms. Apart from the potential complications that are associated with any other types of surgeries, it is not clear why only some patients undergoing spinal surgery have good outcomes, while others do not. It is well known that inflammation in the intervertebral disc is a major cause of disc degeneration (lumbar and cervical discs) in these patients; however, the exact cause and nature of such inflammation is not clearly understood. If the systemic or local inflammation persists even after spinal surgery, then it is unlikely that the surgery will have any beneficial outcome on the remission of pain. This necessitates the development of a more personalised pre-operative diagnostic approach to predict which back pain and neck pain patients undergoing a spinal surgery are likely to have good outcomes.
How can you help: The research study aims to determine if back/neck pain patients with good outcomes (66% reduction in pain at least 6 months after surgery) after spinal surgery have different types of bacteria in their body when compared to the patients with bad out-comes. It is evident that spinal surgery is the most common form of surgery performed in chronic neck pain patients to manage refractory pain arising due to degenerative intervertebral disc. We will investigate this by collecting different specimens (blood and stool samples, oral swab and skin swab) before surgery from participants which will be used to generate bacterial sequences in our laboratory that will allow us to determine the if patients with good outcomes have different types of bacteria in and on their body compared to the patients with bad outcomes after spinal surgery.
4. The DDCM Study
Imagine if you could track the progression of your neck pain and treat accordingly?!
What we want to know: Do patients with degenerative cervical myelopathy (DCM) have different metal ions in the spinal cord and gut bacteria compared to healthy people?
Background: Degenerative cervical myelopathy (DCM) is a common spinal cord disorder caused by chronic progressive compression of the spinal cord. It is a degenerative condition which occurs due to nontraumatic, progressive, and chronic compression of the cervical spinal cord. With ageing, the frequency, severity, and number of levels increase significantly. Despite significant advances, our knowledge of the exact cause of this disease pathogenesis is surprisingly lacking. Despite important technological advances, cervical myelopathy remains a clinical diagnosis. Components needed to make this diagnosis include a history of myelopathic complaints, findings in the physical examination suggestive of myelopathy and advanced imaging studies showing compression of the spinal cord.
However, patients with this condition may have very subtle clinical findings and often, not all three of the before mentioned diagnostic elements are met. These entails the development of novel tools for molecular understanding of the disease progression and diagnosis.
How can you help: The research study aims to determine if neck pain patients with myelopathy have (1) different iron and calcium levels and (2) bacteria in the stool and mouth compared to healthy people. We understand that managing neck pain is a significant problem and we need to know more about the disease. We will determine the iron and calcium contents (using MRI), and bacteria in your body (stool, oral swab and blood). Moreover, we will ask you questions about your neck pain during the course of the study.
5. The DeVa Study
Contribute to the development of new & faster MRI techniques- the future of back pain imaging will be here soon!
In research, MRI scans of the spinal discs to diagnose degeneration are assessed quantitatively by applying computer algorithms to determine the “true” value in each pixel and adjust for random measurement error/noise, because this has been shown to be more accurate than using raw values.
However, in general clinical use the simple measured raw value is used because existing quantitative algorithms take a very large amount of time to process. Repeated surveys of radiologists show the main barrier to introducing better techniques to practice is that the amount of time taken to process these scans is so long that it threatens the profitability of their businesses, meaning these more accurate techniques are.
Our group has been working to develop faster processing algorithms that are as least as accurate and not tied to a particular vendor (i.e. brand) of MRI so that any radiologist can use them. In a research MRI scanner in rabbits our algorithm is between 5 and 1800 times faster than existing post processing algorithms, and in fact moderately more accurate in the diagnosis of disc degeneration. In contrast to most algorithms developed by for-profit corporations which are kept secret, we have openly published the entire algorithm in a major spinal research journal this year.
Our hypothesis is that we will be able to process the same images that existing techniques use, but in no more than one fifth of the time, while still maintaining the same accuracy as existing quantitative algorithms. This is important because if we can reduce the time taken to perform the computer post-processing for human whole lumbar spine images from half an hour to 5 minutes or less it will remove the main barrier to quantitative MRI actually entering clinical practice.
Building on the results from TAO study, PSR is an observational cohort study of patients undergoing lumbar interbody spinal fusion (by any method), to assess the predictive value of a particular MRI scan processing technique (decay variance). Many surgeons perform such operations using the diagnosis of “intervertebral disc degeneration” on MRI. However, current diagnostic techniques using MRI perform poorly, and are not well correlated to pathological changes in the intervertebral disc. There is, evidence that changes on T2 MRI (the dominant technique in clinical practice) is not correlated with surgical outcomes. Hence, Failure rates from spinal fusion are high.
Our team has described a technique using post-processing of standard MRI images that correlates almost 100% with intervertebral disc degeneration on pathology. We have named this technique as DeVa for decay variance in the MRI signals. We wish to determine whether the DeVa analysis of MRI scans translates into predicting surgical outcomes and predicting which patients are unlikely to benefit from operations in advance.