Knee Aspiration and High Definition MRI for ACL Injury

May 24, 2021 updated by: Mr Stephen McDonnell, Cambridge University Hospitals NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Last visit, usually 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Identification of acute inflammatory mediators measured by NanoString molecular analysis
Time Frame: Last visit, usually 28 days
Last visit, usually 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2019

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 26, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A095100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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