The BASS trainee committee would like to invite you to participate in the National Study - CSF Leak Incidence and Plan - CLIP Study.

The CLIP study is our new national prospective, multicentred, trainee-Initiative study. Building on the success of the MoveCom study we wish to create a model whereby the BASS members can collaborate to create a substantial work of research to answer clinically relevant and important questions.

Please find details about the CLIP study below:
Name: CLIP - CSF Leak Incidence and Plan
Type of Study: National, prospective, observational study. 
Aims: To assess current practice regarding managing dural tears throughout centres in terms of immediate surgical treatment, imaging and management within neurosurgical and orthopaedic units
Study duration: 6 months, data collection to commence Jan 2023
Benefit for collaborators: All collaborators and data collectors shall be recognised with collaborator status / collaborative authorship on any presentation or publication

• Study Invitation (.pdf)
• Study Design (.pdf)
• Rules of Engagement (.pdf)

All collaborators that sign up will receive a toolkit regarding the study providing future information. We are very excited to share this opportunity with you - our BASS members. We hope you will join us in making this a successful collaborative project. Please use the registration link below to join our study group.

Registration form: https://forms.gle/YEt7jr6923gv6qe27

Best wishes,
CLIP Study Team - clipstudyBASS@gmail.com
BASS Trainee Committee

The treatment for patients with thoracolumbar burst fractures without neurological deficit or definite rupture of the posterior ligament complex is controversial and includes both surgical and non-surgical options. The aim of this study is to compare surgical to non-surgical treatment in patients with thoracolumbar burst fractures without neurological deficit and/or definite rupture of the PLC.  

The SunBurst study is an international, multicentre, randomized controlled trial (clinicaltrials.gov: NCT05003180). Currently all centres performing spine surgery in Sweden are involved and additional centres in Norway will join during 2022. Patients 18 to 66 years old with burst fractures from Th10 to L3 are eligible for the study. 202 patients will be randomized in a 1:1 relation to either surgical or non-surgical treatment. Patient-reported outcome measures (PROMs) and radiological data will be collected at the time of injury, after 3-4 months and after 1 year.  

Additional centres are welcome to join and can contact:  

Simon Blixt; simon.blixt@ki.se, MD, PhD-student, Karolinska Institutet and Karolinska University Hospital 

Paul Gerdhem; paul.gerdhem@ki.se, MD, PhD, Professor, Karolinska Institutet and Karolinska University Hospital, +46-736-994409 

Link to Leaflet HERE

THE MODIC TRIAL is open for recruitment for participants with moderate to severe Chronic Low Back Pain with Modic 1 or Modic 1 and 2. 

A First in Human study evaluating an intradiscal antibiotic formulation in the treatment of Chronic Low Back Pain with Modic 1 or Modic 1 and 2, THE MODIC TRIAL was set up following pioneering work by Dr Hanne Albert which demonstrated the efficacy of 100 days of oral antibiotics.  The clinical evidence and associated side effects of oral antibiotic treatment was recently reviewed in The Spine Journal

THE MODIC TRIAL is a multi-centre, randomised, double-blind, placebo-controlled trial taking place in the UK, Europe and New Zealand where Regulatory and Ethics approval have been obtained. 

All subjects will have Gd-enhanced MRI scans at baseline, 6 months and 12 months to assess the inflammation/Modic changes in the targeted disc. Efficacy will be assessed over 12 months using patient reported pain and disability scales.

The key inclusion criteria are:

•       Aged 18-70 years

•       CLBP in the area L1 to S1 associated with vertebral body endplate bone oedema (Modic 1) or vertebral body endplate bone oedema and fat (Modic 1 and 2), at a single lumbar level

•       CLBP has lasted > 6 months

•       Moderate-severe pain, back pain greater than leg pain

•       Moderate-severe disability

•       There is no clear alternative cause for back pain

•       Failure of standard of care therapies

•       The target lumbar disc must not have lost more than half its anticipated height at its centre

If you have any patients who are suitable and would like to take part in a clinical trial, referrals can be made to research sites in the UK:

City	Principal Investigator	E mail	Phone
Coventry	Mr Robert Sneath	robert.sneath@uhcw.nhs.uk	+44 2476965067
Oxford	Dr Matthew Scarborough	Matthew.scarborough@ouh.nhs.uk
Preston	Dr Shiva Tripathi	FIH@LTHTR.nhs.uk Shiva.Tripathi@lthtr.nhs.uk	+44 1772 524185

THE MODIC TRIAL is sponsored by Persica Pharmaceuticals Ltd.

Further information can be found at themodictrial.com, clinicaltrials.gov and at persicapharmaceuticals.com

PDF Document Here

Background

Chymodiactin, the previously available product used widely in Europe, North America and many other countries obtained FDA approval in  1982 and also MHRA approval, ceased to be available in 2002.  Abbott Laboratories  had recently bought Knoll Pharma, a subsidiary of BASF, who owned the rights to the product, to gain access to the D2E7 molecule, which became the drug Humira. However Abbot decided not to continue with Chymodiactin and it ceased to be available.  DisCure Medical has been set up with plans to re-introduce Chymodiactin which still has FDA and MHRA approval. However due to the time lapse, some relatively minor changes in the manufacturing process are likely to necessitate a reintroduction by means of a clinical trial as proposed.

Study Design

The study is a single arm prospective study.

Patients with contained disc herniations at the L4-5 and L5-S1 levels will be randomized to injection of 1000 or 2000 pKat of Chymopapain.

Inclusion Criteria

A contained lumbar disc herniation at the L4-5 or L5-S1 level as determined by an MRI, and clinical symptoms corresponding to the location of the herniation.

VAS Leg pain of 50 mm or greater and the ODI exceeding 30.

Examination will have restriction of spinal movements and straight leg raising restricted to at least 45 degrees on the painful leg, with a positive bow string sign,  with or without cross-over pain to the opposite leg.

They will have adequate non-operative treatment for 6 or more weeks which may include medication (NSAIDs and/or analgesics), physical therapy, or spinal injection (epidural or root block), will be between 20 and 65 years of age and have had no previous spinal surgical intervention.

Exclusion Criteria

Disc herniations at more than one level.

Disc herniation extruding through the posterior longitudinal ligament or sequestrated.

Spinal Injection within 3 weeks of informed consent. (epidural or root- block)

Previous spine surgery.

Cauda equina syndrome or a severe rapidly progressing neurologic deficit.

Lumbar spinal stenosis, spondylolisthesis, scoliosis, spinal tumor, spinal infection, ankylosing spondylitis.

Interested?

If you are interested in being involved in this study, please contact me ,

Professor Douglas Wardlaw.  Email dwardlaw@btinternet.com

POLYFIX DCM BASS summary.pdf

POLYFIX - SBNS Update April 2021.pdf

POLYFIX - Trial Synopsis.pdf

DENS_StudyDiagram_protocol_newsletter May 2021.pdf

The Duration of External Neck Stabilisation (DENS) study is a randomised controlled trial comparing early removal of a hard collar with treatment in a hard collar for 12 weeks in older or frail adults with odontoid (dens) fractures. The primary outcome measure is QoL assessed using the EQ-5D-5L at 12 weeks following injury.  The aim of the study is to determine whether management without a collar improves outcome, compared to management with a collar. Cost efficiency will be assessed over the observed 12 months using standard NICE reference case methodology.

We are currently awaiting  REC approval and hope to begin site set up and recruitment from August 2021. If you are interested in taking part and have not already completed a feasiblity study for your site,  please contact the Trial Manager, Angela Niven (Dens.Trial@ed.ac.uk) or the Chief Investigator, Paul Brennan (paul.brennan@ed.ac.uk) 

https://www.ed.ac.uk/usher/edinburgh-clinical-trials/our-studies/all-current-studies/dens