Knee injury and the biological basis for outcomes: How does local and systemic inflammation affect outcomes including pain and function following knee injury, a prospective observational study
| ISRCTN | ISRCTN71112565 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71112565 |
| IRAS number | 340204 |
| Secondary identifying numbers | IRAS 340204 |
- Submission date
- 05/06/2024
- Registration date
- 11/07/2024
- Last edited
- 18/06/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
This study aims to find out if there is a link between knee injury and pain that is mainly from the brain and spinal cord and not from the knee. The researchers will perform tests on the knee and use patient questionnaires to assess this. It is possible that the pain is linked to inflammation so blood samples and fluid from the knee will be taken to test this.
Who can participate?
Patients over 18 years old who have suffered a fracture that involves the knee joint
What does the study involve?
The study involves taking samples of blood and knee fluid up to three times after the injury, as well as two stool samples. Then as an outpatient patients will be reviewed every 3 months where they will undergo specialist knee pain tests and complete questionnaires on their pain and function.
What are the possible benefits and risks of participating?
There is a small risk of discomfort and infection from the sampling procedures. Occasionally aspiration of a swollen joint can have a pain-relieving effect.
Where is the study run from?
University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
February 2023 to July 2028
Who is funding the study?
NIHR Biomedical Research Center - Nottingham (UK)
Who is the main contact?
Chris Busby, christopher.busby@nhs.net
Contact information
Public, Scientific, Principal Investigator
Academic Orthopaedics
C-floor, West Block
Queens Medical Centre
Nottingham
NG72UH
United Kingdom
 ORCID ID |
0000-0002-2840-5558 |
|---|---|
| Phone | +44 (0)776251726 |
| christopher.busby@nhs.net |
Study information
| Study design | Single-center single-cohort descriptive study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Knee injury: evaluation of biological Factors and Clinical Trials Study |
| Study acronym | KneeFACTS |
| Study objectives | To evaluate if certain characteristics (such as injury severity and surgical insult), affect the inflammatory response in individuals with knee injury and if this has a relationship with psychology. This will improve our knowledge about the relationship between knee injury, surgery, psychological distress, pain and inflammation, which will help in advancing interventions to improve health outcomes. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Development of centrally mediated pain in knee trauma |
| Intervention | Recruitment will be of patients with an intraarticular knee injury, both conservatively treated and operatively treated. The study involves taking samples of blood and synovial fluid up to three times after the injury, as well as two faecal samples. Then as an outpatient patients will be reviewed every 3 months where they will undergo specialist knee pain tests and complete questionnaires on their pain and function. The analysis of collected samples (blood and synovial fluid) will take place either within the University of Nottingham or transported to commercial providers for specialist analyses where a material transfer agreement has been arranged. |
| Intervention type | Other |
| Primary outcome measure | Changes in cytokine levels and inflammatory marker levels in blood in response to injury at presentation, measured using ELISA at time of surgery (if occurring) at day 3 post-surgery (if still an inpatient), and day 7-8 post-surgery (if still an inpatient) |
| Secondary outcome measures | 1. Changes in cytokine and inflammatory marker levels in knee synovial fluid measured using ELISA at presentation, at the time of surgery (if occurring) at day 3 post-surgery (if still an inpatient), and day 7-8 post-surgery (if still an inpatient) 2. Measured at 6 weeks, 3 months, 6 months, 9 months, 12 months post-injury/operation: 2.1. Changes in post-trauma pain phenotype over time measured with quantitative sensory testing, patient-reported outcome measures (PROMs) (numerical rating scale, central sensitisation inventory, PainDETECT) 2.2. The effect of knee injury on mental health measures measured with the Hospital Anxiety and Depression Scale 2.3. Knee function post-injury measured with PROMS (Knee Injury and Osteoarthritis Outcome Score [KOOS] and Central Aspects of Pain in the Knee [CAP-Knee]) 2.4. Health-related quality of life score changes measured using EQ-5D-5L 3.0 Gut microbiome expression measured using faecal samples on discharge from hospital and at 6 months |
| Overall study start date | 07/02/2023 |
| Completion date | 01/07/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | 1. Adult patients (>17 years old, no maximum age) who attend Nottingham University Hospitals under the care of orthopaedic trauma and are undergoing treatment for intraarticular knee injuries. Must include one or more of the injury groups outlined below and include an intraarticular component as defined in AO Classification (2018): 1.1. Patella fracture 1.2. Tibial plateau fracture 1.3. Distal femur fracture 2. Able to give informed consent 3. Able to complete required questionnaires |
| Key exclusion criteria | 1. Aged 17 years or under 2. Concomitant fracture involving another joint 3. Taking anticoagulants (direct oral anticoagulants [DOACs], warfarin) or coagulopathy 4. Intra articular knee fracture that involves preceding prosthesis or implant. 5. Significant soft tissue injury making aspiration not feasible or safe as determined by one of the investigative team 6. Presence of local (knee) or systemic infection 7. Immunomodulating medication or treatments with systemic impact 8. Systemic chronic inflammatory diseases 9. Active malignancy 10. Pregnancy or breastfeeding 11. People in the custody of the police or incarcerated persons 12. Inability to read or write English. 13. People with significant mental health disease under section |
| Date of first enrolment | 01/08/2024 |
| Date of final enrolment | 01/08/2027 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nottingham
NG81FS
United Kingdom
Sponsor information
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Phone | +44 (0)115 951 5151 |
|---|---|
| sponsor@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Government
Government organisation / Research institutes and centers
- Alternative name(s)
- Nottingham Biomedical Research Centre, Nottingham Biomedical Research Centre - NIHR, NIHR Nottingham BRC, BRC, NIHR NBRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/08/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The results will be published in peer-reviewed journals and form part of a PhD thesis |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository: University of Nottingham servers |
Editorial Notes
05/06/2024: Study's existence confirmed by the NIHR Nottingham Biomedical Research Centre.
