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The Centre for Spinal Studies and Surgery (CSSS) places a great importance on both clinical and basic research, striving for constant improvement and development.

Several of our consultants actively take part in research with a dedicated team of research fellows that are active in the consultant's field of interest and a specialised team supporting the administrative needs of the department's clinical trials. 

Below is a list of ongoing clinical trials in the CSSS:

 

Blast Off Study - Bisphosphonate aLternAtive regimenS for the prevenTion of Osteoporotic Fragility Fractures

The purpose of this study is to improve the treatment of osteoporosis and therefore prevention of fragility fractures. Osteoporosis is a condition that makes bones more fragile and therefore more likely to fracture, even after minimal trauma. Current NHS guidelines recommend that people who have osteoporosis should be offered a bisphosphonate treatment first-line (for example Alendronate (Fosamax; Risedronate ( Actonel); Pamidronate; Zolendronic Acid (Zolendronate). Bisphosphonate treatment has been shown to increase bone density and to reduce the risk of fragility fracture by 20-70%, dependent on the site of fracture. However, long term persistence with the most common bisphosphonate treatment Alendronate (or Alendronic Acid) is known to be poor and many patients stop taking the treatment over time. Studies suggest compliance and persistence over two years ranges from 16 to 42%. Poor adherence to osteoporosis medication is associated with long-term consequences such as increase in osteoporotic fractures and healthcare costs. In recent years, alternative forms of bisphosphonate treatment regimens have been developed, but there has not yet been sufficient evidence of the effects of these treatments and in particular their acceptability to patients.

The study as a whole involves a series of related research activities in order to look at how effective different bisphosphonate regimens are at preventing fractures, whether the reduction in fracture risk can be achieved at a reasonable financial cost and to establish the acceptability of different approaches to patients. Your participation in this aspect of the study would involve a semi-structured interview as part of the qualitative study. The information gathered from these interviews will be used to inform the study objectives; in particular which bisphosphonate treatment regimens are most acceptable to patients.

Details of Funder: NIHR Health Technology Assessment (HTA)

 

Assert Study - (Acute Sacral inSufficiEncy fractuRe augmenTation) Randomised Controlled, Feasibility in Older People Trial

 

The bones of the pelvis form a complex ring-like structure. It can break (fracture) after a simple fall from a standing height or less. This is more common in older people, as the bones are more brittle. In a high proportion of people the pelvis can fracture in more than one place. This usually involves the bones in the front of the pelvis and the bone at the back of the pelvis, called the tail-bone or properly known as the sacrum. The sacrum is the large triangular bone at the base of the spine.  A diagram of the pelvis and the types of fractures in the pelvis is shown:

A fractured pelvis can lead to significant pain and disability and often results in a long hospital stay. A fractured sacrum in particular, is associated with difficulty in sitting and moving. On average, at least two weeks are spent in hospital and almost 30% of people with a fractured pelvis become more dependent on personal care.

Treatment of a fractured pelvis involves controlling the pain, and walking as soon as it is possible. This is commonly done with strong pain medicine and physiotherapy. However, the pain can sometimes be difficult to control and strong pain medication such as morphine is often used, but this may lead to problematic side effects such as constipation, nausea and confusion. In recent years, surgery to fix a fractured pelvis, especially a fractured sacrum has been increasingly used. First described in 2002, this type of surgery is performed through keyhole surgery. Patients are given a general anaesthetic and have a special bone cement injected into the fractured sacrum. The fracture is sometimes held together by screws if it is very bad. This is also performed under keyhole surgery. Recent trials have reported good outcomes with quicker pain relief, reduced need for pain medicine, patients getting back on their feet much quicker and with less disability. Whether this should be offered to all patients with a fractured sacrum in terms of helping them to get better quicker and save money for the NHS is unclear.  Therefore before we undertake a large scale study, we plan to do a smaller study here in Nottingham. This will inform us of how best to conduct a larger study in the future.

A total of 48 participants will take part in the study. Participants will be allocated by chance (randomly) to either keyhole surgery to fix the fractured sacrum or no surgery, which is the current treatment for these type of fractures, involving pain medication and physiotherapy. 

Details of Funder: NIHR Research for Patient Benefit Grant

 

SDIM - Spinal Deformity Intraoperative Monitoring


Sponsored by AOSpine

The objective of the study is to understand and manage intraoperative neuromonitoring changes during spinal deformity surgery: a prospective interventional study.

   

 

TROLLEY

The purpose of this study, sponsored by the AO Foundation group, is an evaluation of the Modern Luqué Trolley growth guiding system vs. conventional treatment of early onset scoliosis patients.

 
 
 
 
 
 

 

WOVEN

The OGmend system developed by Woven Orthopedic Technologies is the first piece of technology in the world specifically designed to address loss of screw fixation by focusing on the screw-to-bone interface. By utilising a unique biopolymer, this devices increases the surface area contact between the bone and screw, distribute load transfer, help bone healing and remodeling, promote bone ingrowth, and enhance fixation in both the short-term and the long-term.

 

 

 

  

If you wish for the Centre for Spinal Studies and Surgery to become involved on a future or ongoing trial, please do not hesitate to contact the centre's Research Team at: spinalresearch@nuh.nhs.uk

  

Last updated: November 2019