Knee Aspiration and High Definition MRI for ACL Injury

NCT ID: NCT04901858

Last Updated: 2021-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-22

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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ACL Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Aspiration of haemarthrosis and high definition MRI

Aspiration of haemarthrosis and high definition MRI

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Mr Stephen McDonnell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Stephen McDonnell

Role: CONTACT

01223 217551

Jenny O'Callaghan

Role: CONTACT

01223 217551

Facility Contacts

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Stephen McDonnell

Role: primary

01223 217551

Other Identifiers

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A095100

Identifier Type: -

Identifier Source: org_study_id

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