Knee Aspiration and High Definition MRI for ACL Injury | NCT04901858

Studies
Knee Aspiration and High Definition MRI for ACL Injury

NCT04901858

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Status

Unknown status

Last Update Posted

May 26, 2021Actual

Enrollment

5Estimated

Phase

Not Applicable

Conditions

ACL Injury

Interventions

Aspiration of haemarthrosis and high definition MRI

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 22, 2019Actual

Primary Completion Date

Nov 2024Estimated

Completion Date

Nov 2024Estimated

First Submitted Date

Feb 3, 2021

First Submission Date that Met QC Criteria

May 24, 2021

First Posted Date

May 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2021

Last Update Posted Date

May 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mr Stephen McDonnell, Principal Investigator, Cambridge University Hospitals NHS Foundation TrustPrincipal Investigator

Lead Sponsor

Cambridge University Hospitals NHS Foundation TrustOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aspiration of haemarthrosis and high definition MRI	Diagnostic Test	Aspiration of haemarthrosis and high definition MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephen McDonnell	Contact	01223 217551		sm2089@cam.ac.uk
Jenny O'Callaghan	Contact	01223 217551		jennifer.ocallaghan@nihr.ac.uk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cambridge University Hospitals NHS Foundation Trust	Recruiting	Cambridge			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided