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Knee Aspiration and High Definition MRI for ACL Injury

Primary Purpose

ACL Injury

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aspiration of haemarthrosis and high definition MRI
Sponsored by
Cambridge University Hospitals NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ACL Injury

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cambridge University Hospitals NHS Foundation TrustRecruiting

Outcomes

Primary Outcome Measures

Pattern of injury on High Definition MRI measured by comparison with 3t MRI images
Outcome will illustrate any additional benefit of high definition MRI

Secondary Outcome Measures

Identification of acute inflammatory mediators measured by NanoString molecular analysis

Full Information

First Posted
February 3, 2021
Last Updated
May 24, 2021
Sponsor
Cambridge University Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04901858
Brief Title
Knee Aspiration and High Definition MRI for ACL Injury
Official Title
Pilot Study Into the Structural Local Molecular Environment Following an ACL Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cambridge University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Aspiration of haemarthrosis and high definition MRI
Intervention Description
Aspiration of haemarthrosis and high definition MRI
Primary Outcome Measure Information:
Title
Pattern of injury on High Definition MRI measured by comparison with 3t MRI images
Description
Outcome will illustrate any additional benefit of high definition MRI
Time Frame
Last visit, usually 28 days
Secondary Outcome Measure Information:
Title
Identification of acute inflammatory mediators measured by NanoString molecular analysis
Time Frame
Last visit, usually 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen McDonnell
Phone
01223 217551
Email
sm2089@cam.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny O'Callaghan
Phone
01223 217551
Email
jennifer.ocallaghan@nihr.ac.uk
Facility Information:
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen McDonnell
Phone
01223 217551
Email
sm2089@cam.ac.uk

12. IPD Sharing Statement

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Knee Aspiration and High Definition MRI for ACL Injury

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