ISTM

Having completed her PhD in ISTM, and a period in 2010 as Researcher in Residence under the Bridging The Gaps, Dr Sarah Griffiths is currently the manager for orthopaedic clinical trials at University Hospital of North Staffordshire.

Dr Sarah Griffiths is currently the manager for orthopaedic clinical trials. Those in development include:

• spinal research (multiple myeloma, IVD regeneration),
• hip studies.

The orthopaedics team at UHNS is always interested in new ideas and research questions that may lend themselves to clinical trials, and are keen to participate with researchers throughout Keele University. If you have a research proposal or idea you want to attach a clinician to or look into human clinical trials for, please don't hesitate to contact Sarah as we can help in the development of the proposal, funding and regulatory authorisation.

STEMM - (Stem Cell-enhanced Modified Microfracure for Articular Cartilage Repair) - Pilot study aiming to establish preliminary data under GMP conditions in our new purpose built clean room facility, for the collection and expansion of mononuclear cells from patient donated bone marrow and blood samples. The goal is to develop a fully operating service to UHNS for delivery of cell therapy for repair of cartilage defects in the knee. Chief Investigator Dr Nick Forsyth from Keele University ISTM, Principal Investigator Mr David Griffiths, UHNS. Ongoing until early 2012.

FASTER - (Fracture Fixation Ankle Surgery: use of Tourniquet and Early Recovery Management Trial) Two-stage blinded randomised controlled trial recruiting >200 patients with ankle fractures at UHNS and Telford's Princess Royal Hospitals. We will investigate whether a tourniquet should be used during surgery for closed ankle fractures? Also concurrently do patients recover better through early removal of a cast to allow early mobilisation and weight-bearing? We will also be investigating the implications of using a tourniquet on health economic cost benefits for NHS and from a societal cost perspective. Implications of early plaster cast removal and mobilisation on cost benefits to NHS and from a societal cost perspective. Chief Investigator Damian McClelland. Study Period January 2012-15.

TOPKAT – (Total or Partial Knee Arthroplasty Trial), single layer, multi-centre randomised controlled trial, with UHNS acting as a participating site recruiting patients eligible for either Total or Uni-compartmental knee replacement surgery. Study aims, to assess the clinical effectiveness of these replacement methods, and to assess the cost effectiveness. Chief Investigator David Beard from Oxford University, total participants to be recruited 500 over study period April 2009-2019. Local Principal Investigator M

DRAFFT - (UK Distal Radius Acute Fracture Fixation Trial) a randomised controlled trial comparing percutaneous fixation with Kirschner Wires versus Volar Locking-plate fixation in the treatment of adult patients with a dorsally displaced fracture of the distal radius. Chief Investigator Matthew Costa, Coventry and Warwickshire NHS trust. Local Principal Investigator Kevin Smith (UHNS).

AIM - (Ankle Injury Management) a pragmatic multi-centre randomised controlled tiral comparing close contact casting technique (CCC) to open surgial reduction and internal fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60years. Chief Investigator Keith Willett from John Radcliffe Hospital, Oxford. Local Principal Investigator Damian McClelland (UHNS).

DUPUYTRENS - (The Molecular Genetics of Dupuytren’s Disease) a retrospective and prospective study looking at over 5000 participants over 3 years, where interventions include, collection of saliva for DNA extraction from patients who have had, or are listed for, surgery for Dupuytren’s disease and collection of spare tissue at the time of surgery for Dupuytren’s disease. Local Prinicpal Investigator Peter Thomas (UHNS).

ProFHER – (Proximal fractures of the humerus: evaluation by randomisation) a pragmatic randomised controlled trial of surgical versus non-surgical treatment of proximal humeral fractures involving the surgical neck in adults. The primary aim is to obtain reliable evidence of effectiveness and cost-effectiveness of basic treatment strategies for the majority of displaced fractures of the proximal humerus in adults. Chief Investigator Professor Amar Rangan, James Cook University Hospital and Trial Manager Stephen Brealey, University of York. Local Principal Investigator Damian McClelland (UHNS).

ACTIVE (Autologous Chondrocyte Transplantation/Implantation verus Existing Treatments for Chondral Defetcs in the Knee) - Large simple multi-centre trial in which patients are randomised to either ACI or the "best alternative" non-ACI treatment. Patients in the ACI arm are further randomised to periosteum or a manufactured collagen membrane. The non-ACI treatment arm may have debridement, abrasion, drilling, mircrofracture, or mosaicplasty, according to clinical indication. Patients re followed up over a 10 year period. Chief Investigator Proff James Richardson, Oswestry, Local Principal Investigator David Griffiths (UHNS).

ISTM research theme: 1. Bioengineering & Therapeutics