The Genomics Of Arthroplasty Infection (GAIN) Study
Research type
Research Study
Full title
The Genomics Of Arthroplasty Infection (GAIN) Study: Understanding Host and Pathogen Genomic Signatures In Prosthetic Joint Infection and Loosening (Student Study)
IRAS ID
182210
Contact name
David A. George
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2016/06/58 Medical Research, UCL Data Protection Registration
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Infection following joint replacement is a devastating complication and a challenging problem. Approximately 10,000 revision hip and 6000 revision knee replacements were undertaken in the UK in 2012 due to implant failure. The main causes were due to aseptic (infection-free) loosening, and infection. Infection occurs in approximately 1-2% of new joint replacement procedures, and up to 5% of aseptic revision procedures. The management of joint infections is often requires a prolonged course of antibiotics, and surgery to change the implant resulting in prolonged rehabilitation, reduced joint function, and increased cost to healthcare system.
The inflammatory processes driving orthopaedic implant failure, whether or not triggered by infection remain unclear and may be influenced by host co-morbidities and genetics. This preliminary study combines experimental approaches targeting both the diagnosis of a pathogen (pathogen-directed) and host inflammatory process (host-directed) response to implant loosening, with or without infection.
Host-directed analysis will involve a detailed examination of the genomic transcriptional signatures within the environment at the heart of loosening and infection in knee and hip implants. To achieve this we will use next-generation genetic sequencing (NGS) to firstly obtain a baseline of what “normal” looks like in patients with no signs or symptoms of either inflammation, infection or loosening, undergoing surgery for unrelated causes. This baseline will be compared to material either obtained from patients with infection, and from patients whose implants are loose but not considered infected.
Pathogen-directed analysis will further use NGS to detect the presence of infectious organism(s) within such tissues, using classical culture-mediated results as a “gold standard”.
We anticipate that this work has the potential to not only provide valuable insights into these poorly understood pathologies, but also prompt the possibility that better diagnostics can lead to better, more evidence-based management strategies and clinical outcomes.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0180
Date of REC Opinion
27 Jun 2017
REC opinion
Further Information Favourable Opinion