ACL InjuryNCT04901858
Knee Aspiration and High Definition MRI for ACL Injury
A study testing Aspiration of haemarthrosis and high definition MRI in people with ACL Injury, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- Aspiration of haemarthrosis and high definition MRI
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2019to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge
Stephen McDonnell, 01223 217551, sm2089@cam.ac.uk
About this study
Official title: 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.
- Conditions
- ACL Injury
- Being tested
- Aspiration of haemarthrosis and high definition MRI
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration of haemarthrosis and high definition MRIDiagnostic test
Aspiration of haemarthrosis and high definition MRI
What is being measured
The primary outcome is the main question the study is designed to answer.
Pattern of injury on High Definition MRI measured by comparison with 3t MRI images
Outcome will illustrate any additional benefit of high definition MRI
Measured: Last visit, usually 28 days
Secondary outcomes (1)
Identification of acute inflammatory mediators measured by NanoString molecular analysis
Measured: Last visit, usually 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start22 Nov 2019
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Stephen McDonnell, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901858
- Sponsor's protocol ID
- A095100
- Status last verified
- May 2021
- First submitted
- 3 Feb 2021
- Last updated
- 26 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Into the Structural Local Molecular Environment Following an ACL Injury
- ClinicalTrials.gov ID
- NCT04901858
- Acronym / sponsor ID
- A095100
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspiration of haemarthrosis and high definition MRIAspiration of haemarthrosis and high definition MRI | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Identification of acute inflammatory mediators measured by NanoString molecular analysis
Time frame: Last visit, usually 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration of haemarthrosis and high definition MRI in people with ACL Injury, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen McDonnell (01223 217551, sm2089@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pattern of injury on High Definition MRI measured by comparison with 3t MRI images (time frame: Last visit, usually 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.