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NCT04901858 Clinical Trial

Knee Aspiration and High Definition MRI for ACL Injury

ACL Injury Clinical Trial

Official title:
Pilot Study Into the Structural Local Molecular Environment Following an ACL Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04901858
Other study ID # A095100
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 22, 2019
Est. completion date November 2024

Study information
Verified date May 2021
Source Cambridge University Hospitals NHS Foundation Trust
Contact Stephen McDonnell
Phone 01223 217551
Email sm2089@cam.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this pilot study is to understand the biological changes that occur within the knee joint following injury to the anterior cruciate ligament (ACL). This will be achieved through aspiration and analysis of the haemarthrosis which fills the knee following injury. The study will look at inflammatory and healing responses using DNA, RNA and protein analysis. This, combined with high resolution imaging of the knee and surrounding soft tissue structures, may enable a more patient specific approach to treatment of ACL injury.

Recruitment information / eligibility
Status Recruiting
Enrollment 5
Est. completion date November 2024
Est. primary completion date November 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Diagnosis of ACL injury confirmed by MRI - All participants must have the capacity to provide informed consent to participate - Participants must be able to comply with required study visit Exclusion Criteria: - Participants outside of the specified age range - Participants who do not have the mental capacity to make informed decisions - Participants who have meniscal pathology or other injuries requiring urgent surgery

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Aspiration of haemarthrosis and high definition MRI
Aspiration of haemarthrosis and high definition MRI

Locations
Country Name City State
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge

Sponsors (1)
Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pattern of injury on High Definition MRI measured by comparison with 3t MRI images Outcome will illustrate any additional benefit of high definition MRI Last visit, usually 28 days
Secondary Identification of acute inflammatory mediators measured by NanoString molecular analysis Last visit, usually 28 days
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