Rupture of Anterior Cruciate LigamentNCT02300012
A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls
A study testing Surgeons knowledge of pre-operative PBIs in people with Rupture of Anterior Cruciate Ligament, run by United Lincolnshire Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000. Performance Based Investigations (PBIs) can be used to evaluate and select correct approaches to patient treatment, and biochemical, biomechanical and physiological biomarkers in other conditions are sensitive in distinguishing between… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- Surgeons knowledge of pre-operative PBIs
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2015to 20 May 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- unilateral ACL rupture
- 18 - 45 years old
Who cannot join
- combined posterior and ACL rupture
- multi-ligament instability including medial or lateral collateral ligament injury
- other lower limb surgery <3mths
- current significant acute injury affecting other lower extremity joints, or other relevant neurological or musculoskeletal pathology.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
United Lincolnshire Hospitals NHS Trust
Lincoln, Lincolnshire, LN2 5QY
About this study
Official title: A Pilot Study to Investigate Biomarkers in ACL Patients and Healthy Controls
Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.
Performance Based Investigations (PBIs) can be used to evaluate and select correct approaches to patient treatment, and biochemical, biomechanical and physiological biomarkers in other conditions are sensitive in distinguishing between disease state severities, type of injuries and responsiveness to treatment. Despite the measurement sensitivity of PBIs, these are not widely used possibly owing to their focus postoperatively where benefits are less worthwhile.
This study aims to investigate novel biomarkers as performance based investigations (PBIs) to improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients. The objectives are to identify whether biomarkers, collected before and after operations, can: 1) Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to predict the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help further understand ACL injuries.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- Surgeons knowledge of pre-operative PBIs
- Keywords
- Anterior cruciate ligament, Performance based investigations
- 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.
Surgeons knowledge of pre-operative PBIsProcedure or surgery
Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice
| Study group | Role | What they receive |
|---|---|---|
| Operation - No PBI | No intervention | Patients requiring operation - baseline PBI data not seen by surgeon |
| Operation - PBI available | Experimental | Patients requiring operation - baseline PBI data seen by surgeon pre-operatively Receives: Procedure: Surgeons knowledge of pre-operative PBIs |
| Non-operation | No intervention | Patients with ACL rupture not requiring operation |
| Control | No intervention | Healthy age matched volunteers - No operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat.
Measured: Baseline, 6 weeks
The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat
Measured: Baseline, 6 months
The change in peak vertical ground reaction force from baseline to 6 weeks post-ACL reconstruction, measured when performing a novel isometric task during sitting.
Measured: Baseline, 6 weeks
The change in peak vertical ground reaction force from baseline to 6 months post-ACL reconstruction, measured when performing a novel isometric task during sitting.
Measured: Baseline, 6 months
The change in anterior-posterior centre of pressure displacement from baseline to 6 weeks post-ACL reconstruction, measured when performing a 10 second standing balance task.
Measured: Baseline, 6 weeks
The change in anterior-posterior centre of pressure displacement from baseline to 6 months post-ACL reconstruction, measured when performing a 10 second standing balance task.
Measured: Baseline, 6 months
The change in time taken to complete a sit-to-stand task, from baseline to 6 weeks post-ACL reconstruction
Measured: Baseline, 6 weeks
The change in time taken to complete a sit-to-stand task, from baseline to 6 months post-ACL reconstruction
Measured: Baseline, 6 months
Secondary outcomes (5)
The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction
Measured: 6 months post-ACL reconstruction
The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction
Measured: 6 months post-ACL reconstruction
The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction
Measured: 6 months post-ACL reconstruction
The change in International Knee Documentation Committee subjective knee evaluation form from baseline to 6 months post-ACL reconstruction
Measured: baseline to 6 months post-ACL reconstruction
The difference in bone morphogenetic protein-7 (BMP-7) between smokers and non-smokers who undergo ACL reconstruction
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start5 Jan 2015
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Anterior Cruciate LigamentStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Lincolnshire Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lincoln
- Responsible party
- Sponsor
- Investigators
- Prof David Mullineaux, PhD, Principal investigator, University of Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300012
- Sponsor's protocol ID
- 120614Mullineaux
- Status last verified
- May 2022
- First submitted
- 23 Oct 2014
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Biomarkers in ACL Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT02300012
- Acronym / sponsor ID
- 120614Mullineaux
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- Anterior cruciate ligament, Performance based investigations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- United Lincolnshire Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Lincoln
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 24 Nov 2014 (estimated)
- 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.
Incident rates of ACL rupture are greatest in 16-39 year olds at almost 1 in 1,000.
Performance Based Investigations (PBIs) can be used to evaluate and select correct approaches to patient treatment, and biochemical, biomechanical and physiological biomarkers in other conditions are sensitive in distinguishing between disease state severities, type of injuries and responsiveness to treatment. Despite the measurement sensitivity of PBIs, these are not widely used possibly owing to their focus postoperatively where benefits are less worthwhile.
This study aims to investigate novel biomarkers as performance based investigations (PBIs) to improve surgical and treatment strategies in anterior cruciate ligament (ACL) patients. The objectives are to identify whether biomarkers, collected before and after operations, can: 1) Assist the surgeon in decision making; 2) Lead to improved prognosis; 3) Be used to predict the outcomes of prognosis, and; 4) Correlate with disease signs/ smoking to help further understand ACL injuries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Operation - No PBI | No intervention | –Patients requiring operation - baseline PBI data not seen by surgeon |
| Operation - PBI available | Experimental | Procedure: Surgeons knowledge of pre-operative PBIsPatients requiring operation - baseline PBI data seen by surgeon pre-operatively |
| Non-operation | No intervention | –Patients with ACL rupture not requiring operation |
| Control | No intervention | –Healthy age matched volunteers - No operation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- unilateral ACL rupture
- 18 - 45 years old
Key exclusion criteria (4 listed)
- combined posterior and ACL rupture
- multi-ligament instability including medial or lateral collateral ligament injury
- other lower limb surgery <3mths
- current significant acute injury affecting other lower extremity joints, or other relevant neurological or musculoskeletal pathology.
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 |
|---|---|---|
| Surgeons knowledge of pre-operative PBIsSurgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice | Procedure or surgery | Operation - PBI available |
Primary outcome
The change in knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat.
Time frame: Baseline, 6 weeks
The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat
Time frame: Baseline, 6 months
The change in peak vertical ground reaction force from baseline to 6 weeks post-ACL reconstruction, measured when performing a novel isometric task during sitting.
Time frame: Baseline, 6 weeks
The change in peak vertical ground reaction force from baseline to 6 months post-ACL reconstruction, measured when performing a novel isometric task during sitting.
Time frame: Baseline, 6 months
The change in anterior-posterior centre of pressure displacement from baseline to 6 weeks post-ACL reconstruction, measured when performing a 10 second standing balance task.
Time frame: Baseline, 6 weeks
The change in anterior-posterior centre of pressure displacement from baseline to 6 months post-ACL reconstruction, measured when performing a 10 second standing balance task.
Time frame: Baseline, 6 months
The change in time taken to complete a sit-to-stand task, from baseline to 6 weeks post-ACL reconstruction
Time frame: Baseline, 6 weeks
The change in time taken to complete a sit-to-stand task, from baseline to 6 months post-ACL reconstruction
Time frame: Baseline, 6 months
5 secondary outcomes
The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction
Time frame: 6 months post-ACL reconstruction
The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction
Time frame: 6 months post-ACL reconstruction
The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction
Time frame: 6 months post-ACL reconstruction
The change in International Knee Documentation Committee subjective knee evaluation form from baseline to 6 months post-ACL reconstruction
Time frame: baseline to 6 months post-ACL reconstruction
The difference in bone morphogenetic protein-7 (BMP-7) between smokers and non-smokers who undergo ACL reconstruction
Time frame: At time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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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.
Prof David Mullineaux, PhD principal investigator
University of Lincoln
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgeons knowledge of pre-operative PBIs in people with Rupture of Anterior Cruciate Ligament, run by United Lincolnshire Hospitals NHS 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 27 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat. (time frame: Baseline, 6 weeks). The study lists 8 primary outcomes in all. 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 27 May 2022.