Ongoing Clinical Trials

Below is a list of clinical trials in orthopaedic surgery that clinicians at South Tees Hospitals are currently involved with

UK-FROST

United Kingdom frozen shoulder trial (UK-FROST):  A multi-centre randomised controlled trial with economic evaluation and nested qualitative study comparing early structured physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a frozen shoulder (Adhesive Capsulitis). This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme

UKCRN ID: 17719

ISRCTN: 48804508

More information: Frozen shoulder trial

Trial lead and principal investigator- Professor Amar Rangan

Research nurse: Alanna Milne 01642 850850 extension 54954

UK FixDT

UK FixDT: UK fixation of distal tibia fractures trial: A randomised controlled trial comparing intramedullary nail fixation with locking plate fixation for patients with a distal tibia fracture.

UKCRN ID: 13761

More information: Fixation of distal tibia fractures

Trial lead: Professor Matthew Costa

Principal investigator: Mr Ian McMurtry

Research nurse: Alanna Milne 01642 850850 extension 54954

HEALTH

Hip fracture evaluation with alternatives of total hip arthroplasty Vs hemi-arthroplasty (HEALTH): A multi-centre randomised trial comparing total hip arthroplasty and hemi-arthroplasty on revision surgery and QOL in patients with displaced femoral neck fracture. This compares the effectiveness, safety and side effects of total hip replacement (arthroplasty) versus partial hip replacements (hemi-arthroplasty) for patients with hip fractures.

UKCRN 177861

Trial global lead: Professor Mohit Bhandari, McMaster University, Canada

UK lead: Professor Amar Rangan and South Tees Hospitals NHS Foundation Trust is the UK sponsor

Principal investigator: Miss Birgit Hanusch extension 52867

UK co-ordinator: Dr Lucksy Kottam extension 54814

Research nurse: Alanna Milne 01642 850850 extension 54954

SWIFFT

Scaphoid waist internal fixation for fractures trial (SWIFFT):

Cast treatment versus surgical fixation of fractures of the scaphoid waist in adults: – a multi-centre randomised controlled trial.

UKCRN ID:14463

More information: Details of SWIFFT trial

Trial lead: Professor Joseph Dias, University Hospitals of Leicester

Principal investigator: Mr Christopher Coapes

Research nurse: Alanna Milne 01642 850850 extension 54954

UK FASHIoN

UK FASHIoN: UK full RCT of arthroscopic surgery for hip impingement versus best conventional care to compare the clinical and cost effectiveness for patients with symptoms of FAI syndrome.

UKCRN ID: 16806

Trial lead: Professor Damian Griffin

Principal investigator: Mr Craig White

Research nurse: Alanna Milne 01642 850850 extension 54954

MR F STUDY

This is a trial on pathogenesis of the distal forearm fractures in males. The trial aims to monitor any changes in the forearm, hip and spine after a forearm fracture in males.

UKCRN ID: 9327

Miss Birgit Hanusch – Grant holder 01642 850850 extension 52867

The DOSH study

The study of dynamic and static elements of hip fracture patients: An age-matched case control feasibility study.

UKCRN ID: 15740

Principal investigator: Miss Birgit Hanusch;01642 850850 extension 52867

PRO knee assessment – Attune

To Investigate the pre-operative to minimum one year postoperative functional performance improvement for the Attune™ primary, cemented TKA system as measured with the KOOS questionnaire (KOOS-ADL sub-score).

ClinicalTrials.gov Identifier: NCT01746524

Sponsor: DePuy Orthopaedics

Principal investigator: Mr Anthony Hui

WHiTE

The WHiTE study group led by Professor Matt Costa from Warwick University, has developed the WHiTE study to provide a comprehensive follow-up framework for monitoring and assessment of a cohort of patients with hip fractures. This study is being run across 12 UK hospitals and aims to:

Define a core outcome set for hip fracture trials
Assess health care quality following hip fracture surgery
Provide a framework in to which multiple randomised controlled trials can be embedded
One of these embedded RCTs is WHiTE 3:HEMI: A RCT comparing the Thompsons with an Exeter polished taper stem and Unitrax head in patients with a displaced intracapsular hip fracture. WHiTE3 is funded by Stryker UK and lead by Mike Reed from Northumbria NHS Trust. Currently five centres from within the WHiTE group are involved with this trial which aims to recruit 976 patients over the next 2 years. South Tees are one of these five centres and are currently in set-up for both WHiTE and WHiTE3. We aim to start recruiting by end of August 2015.

Principal Investigator for WHiTE- Col. Will Eardley

Principal Investigator for WHiTE3 HEMI- Mr. Paul Baker

CARTIVA

CARTIVA for CMC Feasibility Study/ Cartiva® G.R.I.P. Study: A Prospective Study to Evaluate the Safety and Effectiveness of the Cartiva® Synthetic Cartilage Implant for CMC in the Treatment of First Carpometacarpal Joint Osteoarthritis.

The objectives of this clinical study are to evaluate the safety and effectiveness of Cartiva® Synthetic Cartilage Implant (SCI) for CMC in terms of pain relief and improvement in the treatment of first carpometacarpal joint osteoarthritis and to evaluate Cartiva® SCI for CMC device performance in order to establish the parameters for a pivotal trial. We aim to start recruiting by December 2015.

Study Sponsor- Cartiva Inc., Alpharetta, USA

Principal Investigator- Mr. Sanjay Miranda