Full title
PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations: The PERISCOPE trial
Background
Rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are common forms of inflammatory arthritis.
They are caused by an overactive immune system and are treated with medicines that reduce this. In recent years, biologics (immune-suppressing medicines) have been developed and are effective in controlling the arthritis however, increase the risk of some infections.
People with inflammatory arthritis sometimes need surgery (e.g., joint replacement) to relieve pain and improve function. There is potential for an increased risk of surgical site infections, which is associated with long-term pain and the need for further surgery.
Currently, biologics are stopped before any planned operation to try and reduce the risk of infection and other complications (e.g., slow wound healing). Stopping biologics increases the risk of painful and debilitating flares, delaying recovery from surgery. Flares are treated with steroids, which can also increase infection risk and delay recovery from surgery.
There are currently no randomised trials that support the current guidelines for stopping biologics before surgery.
What we are doing
We have designed this study with our patient advisory group which includes people with arthritis, treated biologics and experience of orthopaedic surgery.
Patients with inflammatory arthritis, on biologics and requiring orthopaedic surgery from several centres across the United Kingdom.
Patients will be randomly assigned to either stopping or continuing their biologics before orthopaedic surgery. This will include all types of orthopaedic surgery, from minor operations to major joint replacements.
We will conduct regular assessments of patients, including quality of life, in the first 12 weeks after surgery. We will also ask patients questions about their health and wellbeing periodically over 12 months. We will record complications, disease activity, medications, how often people seek care and who with.
We will also compare the costs and interview patients and healthcare professionals to understand their views and experiences.
Co-chief investigator
Professor Hemant Pandit and Associate Professor Kulveer Mankia
Co-investigator
Professor Amar Rangan
Sponsor
Leeds University
Funder
NIHR Health Technology Assessment (HTA)
Current status
In set up