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

Not Applicable

• Conditions: Development of centrally mediated pain in knee trauma; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN71112565
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-11
• Last Update Posted: 22 July 2024
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)<br>2. Measured at 6 weeks, 3 months, 6 months, 9 months, 12 months post-injury/operation:<br>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)<br>2.2. The effect of knee injury on mental health measures measured with the Hospital Anxiety and Depression Scale<br>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])<br>2.4. Health-related quality of life score changes measured using EQ-5D-5L<br>3.0 Gut microbiome expression measured using faecal samples on discharge from hospital and at 6 months