NCT04901858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 26, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

May 26, 2021

Status Verified

May 1, 2021

Enrollment Period

4.9 years

First QC Date

February 3, 2021

Last Update Submit

May 24, 2021

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Identification of acute inflammatory mediators measured by NanoString molecular analysis

    Last visit, usually 28 days

Interventions

Aspiration of haemarthrosis and high definition MRIDIAGNOSTIC_TEST

Aspiration of haemarthrosis and high definition MRI

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Central Study Contacts

Stephen McDonnell

CONTACT

01223 217551sm2089@cam.ac.uk

Jenny O'Callaghan

CONTACT

01223 217551jennifer.ocallaghan@nihr.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

May 26, 2021

Study Start

November 22, 2019

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

May 26, 2021

Record last verified: 2021-05

Locations

GB(1)