Ongoing clinical trials

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 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

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

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 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

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 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

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

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 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