Highlights from 2018
Over 2018, one study finished recruitment, three started recruitment and funding for one was successfully secured:
The KReBS study is a randomised controlled trial of the effect of a two-layer compression bandage system compared to usual care (wool and crepe bandaging) following total knee arthroplasty. This study closed to recruitment in August this year, following recruitment of 2338 patients across 26 sites. Patients will be followed up for 12 months.
The ACTIVE trial is a parallel group, multi-centre randomised controlled trial designed to assess the clinical and cost-effectiveness of internal plate fixation (using a plate and screws) versus external fine wire fixation (using a ring frame or cage) for the management of Type C pilon fractures of the distal tibia.
The study includes an internal pilot phase, with an associated qualitative study, which aims to assess the assumptions about recruitment and provide guidance on optimising the trial processes.
Participants will be followed up at 6 and 12 months post-randomisation. Recruitment began in March 2018.
PRESTO is a three-centre study aiming to assess the feasibility of conducting a large randomised controlled trial comparing surgical fixation with initial non-operative management in patients with stable thoracolumbar fractures.
The study also includes a qualitative element to explore patient and clinician experience and barriers to recruitment and randomisation and a UK wide survey of surgeons who treat thoracolumbar fractures to capture information on current management strategies, methods of treatment, willingness to randomise to a future trial and current caseload.
The 12 month recruitment period began in April 2018.
The ProFHER-2 trial will assess whether reverse shoulder arthroplasty is more effective than hemiarthroplasty as an option for shoulder replacement surgery to restore use of the shoulder and arm in patients for whom the shoulder bone is fractured into more than two parts or are widely separated.
It will also investigate whether shoulder replacement surgery is more effective than non-surgical treatment for these fractures. Patients 65 years or older, with complex fractures of the proximal humerus, are invited to take part in a randomised controlled trial comparing the three treatments.
QIST is a randomised controlled trial looking at the effectiveness of the Breakthrough Series Collaborative (BSC) model for introducing service improvements in the NHS. BSCs bring together teams from Trusts seeking to make specific changes. The Trusts have been randomised to receive training in how to introduce a pre-operative protocol either for reducing MSSA or to treat anaemia in patients undergoing hip or knee replacements. The Trusts act as controls for each other and at the end of the trial will be given the option of training in the alternative protocol. The trial will examine the implementation at each Trust.
Approximately £2million was secured in 2018 for the L1FE trial. Patients 60 years or older, with Lateral Compression type-1 fractures of the pelvis, will be invited to take part in a randomised controlled, parallel group trial comparing surgical fixation using INFIX with non-surgical management. The study includes a 12 month internal pilot.
The primary outcome is average patient quality of life and function at 6 month follow-up, assessed by the patient-reported outcome measure, EQ-5D-5L (measured at 2 weeks, 4 weeks, 12 weeks and 6 months). The study is currently in the early stages of set up with recruitment scheduled to start in March 2019.