Tibial Fracture Management Research - STORM/IOS and Intelligent Orthopaedics Ltd
Submitting InstitutionStaffordshire University
Unit of AssessmentGeneral Engineering
Summary Impact TypeTechnological
Research Subject Area(s)
Medical and Health Sciences: Clinical Sciences
Summary of the impact
Globally, around 400 people in every million head of population will
present with a fracture of the tibia that requires surgical intervention.
This case study describes the exploitation of research that commenced with
a DTI/EPSRC grant. The results have a direct impact on the 400/million
population, their family, employers, and associated healthcare providers.
During the period 2008-today:
over 200 surgeons in 10 countries have been retrained in the new
between 2000-3000 patients have benefited from improved outcomes;
47 hospitals benefited from reduced operating times and reduced costs;
and surgeons benefit from a marked reduction in per-operative x-ray
exposure (reducing the risk of cancer).
The initial project was to identify the optimum movement of the fracture
fragments to promote healing; this was to lead to devices with the
potential for significant impact. A spin out company was formed which has
attracted over £1.4 million investment.
The underpinning research started in 1993 under GR/J55984/01 (£155k).
Professor Ogrodnik and Professor Thomas led the project. Together, with Dr
CI Moorcroft, they have built a recognised centre for the investigation of
human fracture healing. The project's members have grown to include
Staffordshire University, the University Hospital of North Staffordshire
and Keele University. Global partners have been recruited including
teaching hospitals and universities in the UK, Germany and the USA.
The project's aim was to investigate the effect of inter-fragmentary
movement of a fractured tibia on the formation of callus. The hypothesis
was that identifying the optimum movement pattern and then designing a
device that would allow this movement to occur would result in shorter
healing times. Several innovative experimental devices were developed. The
first was a unique theatre based, operative tool. Its aim was to ensure
that all patients in the trial had their fractures reduced to near
anatomical alignment . It is, now, being sold as a stand-alone piece of
operating theatre equipment (STORM) and is used to help align the
fractured bone and to retain its position during fixation. It is the
subject of a number of granted world patents (for example EP0984729 and
US8080016). A unique disruptive technology was also developed: the first
autonomous data logging system to monitor patient activity and fracture
healing progression . This device led to granted patents - for example
EP0740927. The third device was a unique system to monitor fracture
fragment movement in a hospital clinic . This device led to further
research (funded by the NHS under the LORS system) to investigate the
polar non-linear properties of healing callus . Interestingly this
research was the first to demonstrate the effect of smoking on fracture
healing: a statistically significant delay of 4 weeks. This discovery led
to further research ; enabling them to use the by-products of this
team's research to investigate the effects of nicotine at the cellular
The team identified the optimum design criteria for the fixation of
mid-shaft tibial fractures. This led to a new generation of external
fixation (IOS); it being the subject of granted patents (for
example GB2427141). This fixator also incorporates a passive fracture
healing detection system (influenced directly from the research results);
it has been clinically verified. The research has led to a better
understanding of fracture healing progression and, more importantly
fracture healing issues. Current research is concerned with addressing the
issues of atrophic and hypertrophic non-union, and mathematical modelling
of the callus mass is also leading to significant results . Other
centres are starting to use the devices for their own research. For
example German teaching hospitals have undertaken an independent study to
examine the clinical benefits of STORM.
STORM and the research team were finalists in the 2006 Royal Academy of
Engineering MacRobert Award and won the Lord Stafford Award for Innovation
in 2005. STORM and IO were selected by HRH Prince Phillip as an example of
the impact of engineering on society in his article Promoting
Engineering within INGENIA.
References to the research
(1) Moorcroft CI, Thomas PBM, Ogrodnik PJ, and Verborg S, (2000), A
device for improved reduction of tibial fractures treated with external
fixation. Proceedings IMechE Part H: Journal of Engineering in
Medicine, 214 (5), 449-457.
(2) Moorcroft CI, Ogrodnik PJ, Thomas PBM, and Verborg S. (1997). A
data-logging system to monitor bone fracture movement continuously.
Journal of Medical Engineering and Physics. 19(3). 286-290.
(3) Ogrodnik PJ, Moorcroft CI, and Thomas PBM (2001). A fracture movement
monitoring system to aid in the assessment of fracture healing in humans.
Proceedings IMechE Part H: Journal of Engineering in Medicine,
(4) Ogrodnik PJ, Moorcroft CI, and Thomas PBM (2007). Measuring
multi-dimensional, time-dependent mechanical properties of a human tibial
fracture using an automated system.
Proceedings IMechE Part H: Journal of Engineering in Medicine,
(5) Walker LM, Preston MR, Magnay JL, Thomas PBM and El-Haj AJ (2001)
Nicotinic regulation of c-fos osteopontin expression in human-derived
osteoblast-like cells and human trabecular bone organ culture. Bone.
(6) OGRODNIK, Peter, THOMAS, Peter, MOORCROFT, Christopher and MOHAMMED,
Khaja (2013) A multi-directional fracture stiffness model to determine the
principal stiffness properties of a healing human tibia._ Journal Of
Engineering In Medicine - Part H. ISSN 09544119
Details of the impact
- STORM is the commercial name for the reduction device described
earlier; IOS is the external fixator ,
- Both have CE mark and FDA clearance to market and,
- are being commercialised within the spin out company Intelligent
Orthopaedics Ltd (£1.4 million investment).
- generated £123k in sales in 2012 .
- 4 patents have been filed; a new patent granted will minimise the
effort of drilling `blind' holes. [1,2]
- It supports (indirectly) employment in 5 companies in Derby, Leeds,
Littlehampton, Portsmouth and Sheffield [1,3].
- The experience has created a unique centre for medical devices design;
we have supported other industries and institutions [1,4].
- Indirectly this project has supported the exploitation of medical
devices from the 13 West Midlands region's universities through Medical
Interchange; exhibiting their devices at MEDTEC 2008, 2009 and 2010 and
at MEDICA 2010 .
- The company employs postgraduate students from Staffordshire for work
experience and provides internships as a part of their 2nd
year studies in Engineering .
- 30 publications including one research led book.
- The research has been cited in over 300 other publications.
Impacts on Public Policy and Services
- STORM is used in Teaching Hospitals and there is evidence that
registrars are being influenced by this new reduction technique
- STORM has been, and is being used in key hospitals across the world: 7
centres in the USA; 12 in Germany; 22 in the UK (including teaching
hospitals at Cambridge, Manchester, Liverpool and Southampton); and 12
in the rest of the World (Eire, Turkey, Saudi Arabia, Greece, Italy and
Impacts on Society, Culture and Creativity
- Exemplified by peers for innovation and engineering [1,8].
- Papers have been presented at key conferences and meetings and the
research group are invited to present their methods at surgical
continuing professional development events [1,4].
- The main researchers have presented over 14 invited papers or
- To date 2000-3000 patients have been treated with STORM and
about 250 with IOS .
- Shorter operating times reduces exposure to General Anaesthesia:
improving operative mortality [1,5,6,7,9].
- Use of STORM has been shown to produce near perfect reduction
- for the patient this means their leg is as close to normal as
- and producing a causal link (that we are investigating) to improved
healing and a reduction in non-unions[1,5,6,7].
- As improved reduction can be shown to improve prognosis; inherently
reducing the total cost of the procedure [1,6,7].
- The most common reason for litigation (USA) for post-operative issues
related to tibial fractures is rotation of the foot. The near anatomical
reduction produced by STORM eliminates this issue and, hence, reduces
potential litigation costs [1,6,7].
- Use of IOS has shown to reduce healing times; the shortest
being circa 9 weeks. This is 7-8 weeks below the accepted average [1,7];
- Allows patients to be mobile the day after their operation [1,7];
- Allows patients to wear normal clothing, hence promoting return to
- Patients prefer IOS to other methods they have been treated with, even
- IOS has no moving parts potential failure modes have been eliminated;
- regular x-rays have become redundant, minimising direct costs [1,7];
- mechanical failure is no longer a root cause of malunion, saving
circa £9000 per patient .
Impacts on Practitioners and Professional Services
- 200+ Surgeon's have received training in new methods of fracture
- The research has challenged the use of radiographs in fracture
- Using STORM has been shown to shorten operating times by
25-30%. This signifies an overall saving about 1250-2500 operating room
hours: or at least one operating theatre for one year. This reduces
costs significantly [1,5,9].
- An independent German study [1,5] has shown that using STORM reduces
x-ray exposure by 50%.
- It reduces overall cost to the hospital.
- More importantly, it reduces overall lifetime exposure for the
- The study also demonstrated that using STORM reduces the number of
surgical assistants required [1,5];
- reducing the overall cost of the operation.
- STORM has been proposed as a preferred method for the super-patella
method of IM nailing beneficial for the treatment of calcaneal fractures
IOS, when compared with a direct comparator (Orthofix), saves a
hospital over 50% of purchase price [1,10].
- The in-built fracture healing detection system has been shown to be
effective (a 100+ patient study is to be published) [1,7];
- reduction of post-operative complications and pin-site issues means
fracture clinics are shorter [1,7];
- reducing total cost to the hospital .
Sources to corroborate the impact
 Chair, Intelligent Orthopaedics Ltd. (Contact Identifier 3)
 OGRODNIK, Peter Jan, and Peter Brian MacFarlane THOMAS. "SURGICAL
TARGETING GUIDE." WIPO Patent No. 2013017833. 8 Feb. 2013.
 Managing Director, Kirkstall Precision Ltd. (Contact Identifier 4)
 Medical Interchange
 Leitender Oberarzt der Klinik fur Unfallchirurgie
Universitatsklinikum Schleswig-Holstein. (Contact Identifier 1)
 Consultant Orthopaedic and Trauma Surgeon,
University Hospital Southampton. (Contact Identifier 2)
 Consultant Orthopaedic and Trauma Surgeon,
Robert Jones and Agnes Hunt Hospital. (Contact Identifier 5)
 HRH Prince Phillip, (2009). Promoting Engineering, Ingenia,
 Hull P, Whalley H, and Docker C, (2008). STORM - A revolutionary aid
for fracture reduction. Orthopaedic Product News, April. (A)
 NHS supplychain website