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Knee Aspiration and High Definition MRI for ACL Injury

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ClinicalTrials.gov Identifier: NCT04901858
Recruitment Status : Recruiting
First Posted : May 26, 2021
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Mr Stephen McDonnell, Cambridge University Hospitals NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
ACL Injury Diagnostic Test: Aspiration of haemarthrosis and high definition MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study Into the Structural Local Molecular Environment Following an ACL Injury
Actual Study Start Date : November 22, 2019
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

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


Primary Outcome Measures :
  1. Pattern of injury on High Definition MRI measured by comparison with 3t MRI images [ Time Frame: Last visit, usually 28 days ]
    Outcome will illustrate any additional benefit of high definition MRI


Secondary Outcome Measures :
  1. Identification of acute inflammatory mediators measured by NanoString molecular analysis [ Time Frame: Last visit, usually 28 days ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04901858


Contacts
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Contact: Stephen McDonnell 01223 217551 sm2089@cam.ac.uk
Contact: Jenny O'Callaghan 01223 217551 jennifer.ocallaghan@nihr.ac.uk

Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom
Contact: Stephen McDonnell    01223 217551    sm2089@cam.ac.uk   
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
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Responsible Party: Mr Stephen McDonnell, Principal Investigator, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04901858    
Other Study ID Numbers: A095100
First Posted: May 26, 2021    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries