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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

Knee injury: evaluation of biological Factors and Clinical Trials Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN71112565
Enrollment
80
Registered
2024-07-11
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development of centrally mediated pain in knee trauma Injury, Occupational Diseases, Poisoning

Interventions

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

Sponsors

University of Nottingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactChris Busby
christopher.busby@nhs.net+44 (0)776251726

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026