STAR trial
Research type
Research Study
Full title
The STAR trial: Evaluation of a care pathway for patients with long-term pain after knee replacement
IRAS ID
204891
Contact name
Rachael Gooberman-Hill
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
Total knee replacement involves replacing the painful knee joint with an artificial joint. It is a major operation and people often experience some pain in the first three months after surgery. However, around one in five patients report moderate or severe pain after this initial recovery period. We call this ‘long-term’ pain. We know that many people do not receive or seek care for long-term pain. Improving care and support for people with long-term pain after knee replacement will benefit patients, the NHS and society.
Our proposed study will run a trial of a new, best care pathway to see if it is of benefit to patients with long-term pain after knee replacement. We will recruit 380 patients with pain at 3 months after knee replacement from four hospitals in the UK. Two-thirds of patients will be randomly chosen to receive the STAR care pathway and one-third of patients will receive the usual care that their hospital provides. The STAR pathway involves a clinic appointment with a healthcare professional to better understand the possible causes of pain after knee replacement. People will then be referred to see relevant health professionals for treatment as needed, such as physiotherapists, orthopaedic surgeons, GPs, or pain specialists. We may decide that for some people the most appropriate course of action is to regularly monitor their pain, and then begin treatment if the pain worsens. We will ask everyone in the study to complete questionnaires after 6 months and 12 months to see if the STAR care pathway improves patients’ pain. We will also collect information to compare the cost of providing both treatments. The findings from this study will help us to know if providing the STAR care pathway can improve patients’ outcomes after knee replacement and is good value for money to invest NHS resources.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0154
Date of REC Opinion
7 Jul 2016
REC opinion
Further Information Favourable Opinion