PERISCOPE
Research type
Research Study
Full title
PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations: The PERISCOPE trial.
IRAS ID
321501
Contact name
Kulveer Mankia
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN17691638
Duration of Study in the UK
3 years, 2 months, 14 days
Research summary
Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are common forms of inflammatory arthritis. In recent years, special immune-suppressing medicines, called biologics, have been developed, which are very effective in controlling the arthritis disease process and symptoms, but can increase the risk of some infections.
People with inflammatory arthritis often need orthopaedic surgery (e.g. joint replacement) to relieve pain and improve function due to the damage caused by arthritis. However, increased risks for surgical site infections is a particular concern for patients undergoing orthopaedic surgery as these can be associated with long-term pain and need for further surgery. Currently, biologics are usually stopped before any planned operation to try and reduce the risk of infection and other complications such as slow wound healing. However, stopping biologics increases the risk of the painful and debilitating flares and delay recovery from surgery. Flares are often treated with steroids, which can increase the infection risk and delay wound healing.The aim of this study is to explore whether continuing biologics is better for patients’ quality of life than stopping them during the operative period.
394 patients will be recruited from 20 hospitals, they will be allocated to one of these groups by chance.
1. Patients will continue their biologics before undergoing surgery
2. Patients will stop their biologics as per current national guidelines before undergoing orthopaedic surgery.Patients will be followed up with questionnaires at 2, 4, 6, 9, 12, 26, and 52 weeks after surgery. Complications (infections, flares), disease activity, medications, how often people seek care and who with will also be recorded. We will compare costs and interview participants and clinicians to understand their views and experiences.
The findings will guide patients, carers, policy makers and clinicians on whether to stop or continue biologics when people with inflammatory arthritis undergo orthopaedic surgery.
REC name
West of Scotland REC 3
REC reference
23/WS/0049
Date of REC Opinion
24 Apr 2023
REC opinion
Further Information Favourable Opinion