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10 Reasons why X-Bolt is better

Wed, 04 Apr 2012 13:10:28 +0100

1. Stronger hold

- larger frontal load area, compresses bone, greater resistance to push-out

2. Rotational stability

- perpendicular expansion, doesn’t spin femoral head, in-situ fixation

3. Dynamic sliding

- for fracture compression

4. One shot guidewire into femoral head

- no need to squeeze a second guidewire or implant into tight space

5. Smaller nail proximal diameter

- doesn't over-stuff the greater trochanter / gluteal muscles

6. Distal taper and prongs

- for stress modulation at distal tip

7. Simple instrumentation, including all-outside nail instrumentation

- easier for nursing staff as well as for surgeons

8. X-bolt common to nail & plate systems

- reduced theatre inventory and reduced stocking costs

9. X-Bolt Direct

- Low cost, online ordering

10. Value for taxpayer

- Less complications and shorter average bed stay

Failure analysis in femoral neck fractures

Sat, 05 May 2012 17:32:22 +0100

Non-union (29%)
AVN (10%)
Symptomatic hardware (8.5%)
Iatrogenic sub-trochanteric fracture (1.4%)

Combined, the above scenarios contribute to a 40% re-operation rate with internal fixation (Cochrane Review 2009).

Retaining more cancellous bone at the fracture site may optimise vascularity and thus reduce risk of avascular necrosis and non-union. Proponents of cancellous screw fixation argue that smaller diameter screws retain more viable bone than larger diameter sliding hip screw. Below is a table showing the cross-sectional area disturbed/disrupted at the fracture site by different methods of femoral neck fixation, from either the screw, tap or reamer. The X-Bolt disrupts 35% less cross-sectional area than the three cancellous screws option (previously considered best).

Fixation strength and rotational stability within the femoral head, by using the X-Bolt, will further reduce the risk of failure and re-operation. Sliding hip screw constructs have better biomechanical stability over cancellous screws in bending stresses. The X-Bolt has better holding capacity over DHS screws in push-out testing, see below.

Perfecting Hip Nailing

Mon, 19 Mar 2012 16:50:58 +0000

OPINION: Brian Thornes

19/03/2012

Why is hip fracture nailing gaining in popularity?

What still causes trouble and makes it fiddly?

What would be the perfect vital statistics for the perfect nail?

Intramedullary nailing is biomechanically stronger, has less lever-arm and it internally buttresses against fracture collapse. Skin incisions are smaller and there is less external blood loss.

And of course, nailing is just more fun.

But it can be fiddly getting the perfect guidewire into the femoral head, especially if you are fitting two screws into the head. Not so with the X-Bolt; requiring just a single shot to the centre of the femoral head. Rotational stability is assured by the X-Bolt wings deploying orthogonally.

Traditionally there has been a trade-off between putting a large screw into the femoral head whilst keeping as small a proximal diameter nail as possible. The X-Bolt goes through the nail aperture as a 9.0mm bolt, to expand on the far side to 24mm. This allows the proximal nail diameter to be kept relatively small to help preserve the greater trochanter and gluteal muscles.

Stress risers at the distal stem tip traditionally can be problematic. Not just a problem with short nails, long nails also have problems at the distal tip, tickling or protruding the anterior cortex, especially if the there is marked bowing of the femur. The X-Bolt nail has a small distal diameter, with distal taper and stress-relieving prongs at the stem tip.

Taking away the fiddle-factor out of nailing includes a pre-loaded anti-rotation set screw, a surgeon-friendly targeting jig, and comprehensive but simple instrumentation.

X-Bolt Nail vital statistics:

Secure femoral head fixation X-Bolt stronger fixation & rotationally stable

Small proximal nail diameter 14.5mm

Small valgus bend 4deg valgus bend

Distal stress modulation Distal taper and prongs

Simple instrumentation Concise and user-friendly

And the winner is...

Mon, 05 Mar 2012 10:06:03 +0000

29th February 2012.

The Irish Times Innovation Awards: APPLICATION OF R&D

Winner: X-Bolt Orthopaedics

A new medical device invented by Dr Brian Thornes and his team at X-Bolt Orthopaedics will improve the efficacy of current hip fracture treatment and has the potential to reduce the requirement for very costly and often devastating repeat surgery.

The X-Bolt is an expanding bolt device for use in bone fixation in osteoporotic hip fractures. Traditional internal fixation uses bone screws that depend on the hold of the screw threads. The X-Bolt can be likened to a masonry or plasterboard rawl-plug bolt that expands to anchor within the bone, and thus gives a much stronger hold and rotational stability.

Dr Thornes is an orthopaedic surgeon with one successful invention already behind him. The “tightrope” is used in ankle repair surgery and among its more famous recipients is Welsh rugby player Gavin Henson.

Some 2,500 hip fractures are fixed annually in Ireland, mostly in the elderly. Around 5 per cent will require a second operation owing to loss of screw fixation or cut-out. The additional costs associated with cut-out from the additional surgery and prolonged hospital stay are estimated at €4 million per annum in Ireland.

“I got the idea for the X-Bolt when I was putting up my plasma TV on the wall of my apartment a few years ago,” says Thornes. “You needed expanding rawl plugs to fix it to the plasterboard wall. Many elderly people’s bones are soft and crumbly. This makes them similar to plasterboard in consistency and causes fixation problems for traditional screws. I set up the company in 2007 and spent the next few years on its research and development.”

The X-Bolt has been granted a European patent and is patent-pending in the US. Biomechanical data from testing performed in Trinity College Dublin, the University of Limerick, Tallaght IT and Queens University Belfast has allowed regulatory approval by British Standards Institute (BSI) to award the CE Mark for the device and instrument sets for clinical use.

The first patient was successfully treated with the X-Bolt in November of 2011 and it is expected that at least 25 per cent of Irish acute hospitals will stock the X-Bolt by mid-2012.

The next steps will see the X-Bolt undergoing clinical studies in Ireland, in order to publish in medical literature. It hopes to commence exports to the UK and Europe later this year. Exports to the US are also anticipated once FDA approval is granted.

Irish Medical Times: 16th Feb 2012

Fri, 17 Feb 2012 14:22:13 +0000

Developing Medical Device Innovations: The X-Bolt® for hip fractures.

Clinicians play a vital role in the development of medical technologies, writes Dr. Brian Thornes. Doctors and surgeons are often pivotal in defining the concept, as the genesis of an innovation usually starts with a problem that needs solving. Clinicians can also help shape improvements to the new technology, and play an important role for later clinical investigations and obtaining independent scientific evidence.

One current major orthopaedic problem is the burden of hip fractures, typically accounting for 30-40% of all trauma orthopaedic bed occupancy, and approximately €60M p.a. in acute health service costs. Complications of treatment in this elderly patient cohort greatly increase costs and average bed stay. The biggest single mechanical complication of hip fracture fixation is ‘cut-out’, mostly due to osteoporosis and poor bone quality that makes screw purchase difficult.

The inspiration for the X-Bolt® came whilst wall mounting a plasma screen TV using expanding bolts. The design adaptation has taken 3-4 years, beginning with filing patent applications, to sourcing manufacturers and testing prototypes in research institutions around Ireland. Once the concept was proven (the X-Bolt® has a 25% greater resistance to ‘cut-out’), much of the testing was to examine potential modes of failure, and to simplify end-user experience.

All manufacturing processes and test data are audited by a notified body (e.g. NSAI or BSI) to gain CE Mark regulatory approval in Europe, or by the FDA for the United States. Occasionally a clinical investigation is required to demonstrate safety and effectiveness. However, this was not necessary for the X-Bolt®, as predicate device data, coupled with our own biomechanical testing was sufficient for approval, and the X-Bolt® was awarded the CE Mark in September 2011.

The first surgical cases have recently been performed, allowing surgeons to familiarise themselves on the short learning curve, and allowing the design team to tweak minor instrumentation issues. The close interaction with clinician-users here has been very welcome, and is an area where the Irish clinical community can excel, alongside the vast number of indigenous and multinational medical device companies based in Ireland.

Savings are anticipated by reducing complication rates and thus the average acute hospital bed stay. Use of the X-Bolt® should provide estimated healthcare savings of €4M per annum in Ireland. An ethics-approved, randomised, controlled clinical study will commence in Ireland in the coming weeks, to scientifically document the device’s mechanical and economic benefits.

Dr. Brian Thornes, MCh, FRCSI, MBA, is the Founder & CEO of X-Bolt Orthopaedics (www.x-bolt.com), which has recently been shortlisted in The Irish Times Innovation Awards 2012. He also is the inventor of the ankle syndesmosis TightRope® (www.ankletightrope.com).

The Irish Times Innovation Awards 2012

Tue, 24 Jan 2012 13:42:57 +0000

24th January 2012, X-Bolt Orthopaedics is proud to announce that it has been shortlisted for the Irish Times Innovation Awards 2012, in the Application of R&D category.

More to follow...

The ‘Unsolved Fracture'...Now that sounds like a challenge...

Tue, 24 Jan 2012 10:22:41 +0000

OPINION: Brian Thornes

24/01/2012

Intracapsular hip fractures have been dubbed the ‘unsolved’ fracture for almost a century.¹

There is a 40% re-operation rate with internal fixation, reported in a Cochrane Review. This is due to:

Non-union
Avascular necrosis
Poor femoral head fixation (‘cut-out’)

This has lead to the use of hemi- and total hip arthroplasty to circumvent these problems, though may just substitute a different set of short and long-term problems. In a perfect world, perfect reduction and fixation may reduce or obviate the need for hip fracture arthroplasty.

Going back to first principles, to create the optimum environment requires:

Perfect anatomical reduction
Strong, secure femoral head fixation
No rotational forces whatsoever, but allow fracture compression

Perfect reduction requires surgical expertise, and should always be achievable, though sometimes requiring an open reduction.

With the above always achievable, we move on to fixation. The strongest fixation devices in my local hardware store are expanding bolts. The solution thus may come from adaptation of such industrial devices, perfected for ease of surgical use and the clinical environment.

The first issue is the expansion mechanism; it cannot disrupt the fracture reduction, push, pull or rotate the femoral head. Therefore it needs to deploy radially outwards, perpendicular to the axis of the device. Mechanically a scissors-jack works in this fashion, with threads of opposite directions compressing a hinged limb from both ends that will lever upwards. Thus the X-Bolt was conceived.

The second issue is reversibility. The X-Bolt can easily be reversed by counter-rotation of the inner drive screw to retract the expandable limbs.

The third and final issue is preventing rotation. The keyed plate barrel here comes to the rescue. This ensures no rotational forces are transmitted to the reduction or femoral head, either during deployment, or whilst dynamic fracture compression occurs.

A critical look at all historical intracapsular hip fracture failures due to non-union or ‘cut-out’, will inevitably have unwanted femoral head rotation as a major factor.

Will the X-Bolt generation solve the unsolved fracture? It ticks all the boxes, including usability and cost. Clinical use and time will tell...

Reference:

DICKSON, J. A. The” Unsolved” Fracture. J Bone Joint Surg 1953; 35-A, 805.

X-Bolt® now in clinical use

Sun, 29 Jan 2012 16:14:21 +0000

21st January 2012.

The X-Bolt has been used successfully on a number of hip fracture patients and is now available for clinical use. Please contact us for further details and for ordering.

Scientific Presentation at the BOA / IOA Combined Meeting 2011

Wed, 25 Jan 2012 11:09:49 +0000

14th September 2011.

D Gibson, C Keogh, S Morris.

A biomechanical study comparing the dynamic hip screw with an X-Bolt

in an unstable intertrochanteric fracture model of the proximal femur.

ABSTRACT:

Introduction: Lag screw cut-out following fixation of unstable intertrochanteric fractures in osteoporotic bone remains an unsolved challenge. A novel new device is the X-Bolt which is an expanding type bolt that may offer superior fixation in osteoporotic bone compared to the standard DHS screw type device.

Aims: The aim of this study was to test if there was a difference in cut-out using the X-Bolt implant compared with the standard DHS system.

Methods: Specimens of low density surrogate bone (5pcf) were inserted into a simplified biomechanical fracture model and had either an X-Bolt or DHS implant inserted. There were eight samples in each group. The fracture model was tested with an incremental cyclical loading programme in a Material Test System. Displacement, cycle count and force exerted were continuously recorded until cut-out of the implant.

Results: All of the specimens failed by varus collapse with superior cut-out and resulted in an automatic stop of the MTS. Specimens with the X-Bolt implant inserted lasted longer on cyclical count and withstood a greater force at cut-out compared with DHS specimens. The mean number of cycles to cutout in the DHS specimens was 4345 and in specimens with the X-Bolt inserted was 6898. The mean force at which cutout occurred in the DHS group was 1.025kN and in specimens with the X-Bolt inserted was 1.275kN. A statistically significant difference was observed with a P-value of 0.005 and a power of 87.2% with respect to cycle count and a P-value of 0.008 and power 84.8% with respect to force exerted at failure when comparing between the two groups.

Conclusion: This study shows that the X-Bolt device demonstrated superior cut-out resistance and withstood greater loads compared to the DHS in low density surrogate bone in an unstable fracture model under cyclical axial loading.

X-Bolt Orthopaedics receives CE Mark for X-Bolt®

Wed, 25 Jan 2012 09:39:42 +0000

13th September 2011.

X-Bolt Orthopaedics, a Dublin based medical device company today announced that its X-Bolt® device has received CE Mark certification from BSI (British Standards Institute), in accordance with the European Medical Device Directive.

The medical device company (www.x-bolt.com) also announced the commencement of an ethics-approved clinical trial for the X-Bolt® device in both Limerick and Waterford hospitals.

Commenting on the developments, Dr. Brian Thornes, Founder and Chief Executive of X-BOLT Orthopaedics said, “These announcements, in addition to the recently granted European Patent on the X-Bolt® device are important milestones in the company’s development and ensures that the X-Bolt® remains on schedule for release to the UK and European market in the last quarter of 2011.”

Established in 2008, X-BOLT Orthopaedics develops innovative orthopaedic medical devices to facilitate surgery and improve outcomes for trauma and orthopaedic patients.

The X-Bolt® is a novel expanding bolt device that gives significantly better fixation in osteoporotic hip fractures. An aging population combined with osteoporosis has resulted in a growth of hip fracture cases by approximately 5% per annum.

Explaining the complexities for hip fracture injuries, Mr. Niall Hogan FRCSI (Orth), consultant orthopaedic surgeon in Dublin said, “Hip fracture patients are by their nature usually very frail. A high proportion of our acute hospital bed occupancy is taken up with hip fracture patients due to their co-morbidities. This cohort of patients, generally have a longer average bed stay, adding to a greater overall healthcare cost. Complications are not well tolerated by this group of patients. Bone strength and quality is also relatively poor in the elderly due to osteoporosis, which may affect quality of the fixation that in turn may delay mobilisation and discharge from the acute hospital.”

Explaining the benefits of the X-Bolt® for hip fracture injuries, Dr. Brian Thornes outlined, “Hip screw ‘cut-out’ is the single major mechanical complication of surgery, approximately 4% of cases. Care costs multiply considerably with any complication in elderly patients. The X-Bolt® specifically addresses these problems, comprehensive hip plating and hip nailing systems with the X-Bolt® common to both have been designed and biomechanically tested. Worldwide US$1Bn could be saved by significantly reducing cut-out complications or domestically this would translate into a €4M saving in Ireland.”

The X-Bolt® device will be exhibited at the combined British and Irish Orthopaedic Associations annual meeting, in the Dublin Convention Centre from the 14th to 16th of September.

About X-BOLT Orthopaedics

Established in 2008, X-BOLT Orthopaedics, a trading name of SOTA Orthopaedics Limited, (www.x-bolt.com) develops innovative orthopaedic medical devices to facilitate surgery and improve outcomes for trauma and orthopaedic patients.

Company founder and Chief Executive Dr. Brian Thornes previously developed the TightRope® syndesmosis fixation; a surgical technique for ankle injuries primarily associated with sports injuries, which to date has been implanted in over 75,000 cases worldwide. The TightRope® is available worldwide via Arthrex http://www.ankletightrope.com/