Foreign Body Response at the Implant Surface final v1.0
Research type
Research Study
Full title
The Role of Lipids and Proteins in the Foreign Body Response at the Surface of Medical Implants
IRAS ID
357020
Contact name
Ben Ollivere
Contact email
Sponsor organisation
University of Nottingham
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study examines whether specific lipid and protein surface depositions correlate with variations in the foreign body response (FBR) to explanted orthopaedic implants from patients with traumatic bone injuries.
100 participants will be recruited from Nottingham University Hospital (NUH) NHS Trust. These patients will have had a limb injury (bone fractures, non-unions, deformities) which has been managed with a Taylor Spatial Frame (TSF) external fixator system. Participants will be eligible for the study at the point when the TSF is due to be removed or adjusted (due to complete healing or due to adverse inflammation/infection/implant loosening events).
The 1-year study will collect biological samples, hospital data, and a short post-surgical questionnaire will be conducted. Each patient will provide a minimum of three pin implants with intact surrounding blood/tissue. Clinical data, including injury details, treatment, and complications, will be extracted from medical records. Patients will complete a brief questionnaire post-surgery regarding their experiences.
Biological samples will be analysed using enhanced mass spectrometry techniques (Orbi-SIMS, LC-MS), advanced imaging, as well as immunological and biochemical assays. The focus is to determine how immune responses to implanted biomaterials are influenced by surface biomolecules. The study aims to identify correlations between specific lipid and protein depositions on implant surfaces and patient outcomes, such as complete healing or adverse reactions like infection, inflammation, or implant loosening.
By analysing lab results in the context of patient injury, immune response, and clinical outcomes, the study seeks to understand how surface biomolecules contribute to immune-evasive or pro-inflammatory effects in the FBR. These insights may inform future improvements in orthopaedic implant design and biocompatibility, ultimately enhancing patient recovery and reducing complications associated with traumatic injury.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
25/EM/0203
Date of REC Opinion
14 Oct 2025
REC opinion
Further Information Favourable Opinion