Predicting Risk In Management of Infection in Orthopaedics (PRIMIO)
Research type
Research Study
Full title
Predicting Risk In the Management of Infection in Orthopaedics (PRIMIO): developing a risk prediction model for the recurrence of orthopaedic infection after treatment.
IRAS ID
274441
Contact name
Maria Dudareva
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Research question:
Do health factors that impair healing and immunity predict if bone or joint infection comes back after surgery?Why?
Bone and joint infection is painful and difficult to treat, needing both surgery and antibiotics. Infection sometimes returns after treatment. Healing and immunity are weakened by smoking, high blood sugar, being underweight or overweight, and alcohol, as well as some medical conditions. We don't know exactly how much these factors affect whether bone and joint infection is cured. Knowing would help plan the right support for people with bone and joint infection before surgery.What?
People having surgery for bone or joint infection will be asked questions and have a medical record check around the time of surgery, then be followed up for a year from their operation.Where:
Patients will be approached in one specialist bone infection hospital in the UK. Anonymous data will also be used from two clinical trials in the UK, where patients have agreed for their study data to be used for further research.Who:
Adults with bone and joint infections having surgery.How?
Main measurement: how many patients' infections return within 12 months after surgery. This will be decided by a group of doctors who do not know the possible risk factors.Other important measurements: serious adverse events; quality of life; cost of treatment.
Patients will be asked questions at their usual clinic visits, and will be given a questionnaire at the start of treatment and 1 year later.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/0140
Date of REC Opinion
20 Feb 2020
REC opinion
Favourable Opinion