A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls
NCT ID: NCT02300012
Last Updated: 2022-05-27
Study Results
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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COMPLETED
NA
8 participants
INTERVENTIONAL
2015-01-05
2022-05-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Operation - No PBI
Patients requiring operation - baseline PBI data not seen by surgeon
No interventions assigned to this group
Operation - PBI available
Patients requiring operation - baseline PBI data seen by surgeon pre-operatively
Surgeons knowledge of pre-operative PBIs
Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice
Non-operation
Patients with ACL rupture not requiring operation
No interventions assigned to this group
Control
Healthy age matched volunteers - No operation
No interventions assigned to this group
Interventions
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Surgeons knowledge of pre-operative PBIs
Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice
Eligibility Criteria
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Inclusion Criteria
* 18 - 45 years old
Exclusion Criteria
* 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.
18 Years
45 Years
ALL
Yes
Sponsors
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University of Lincoln
OTHER
United Lincolnshire Hospitals NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Prof David Mullineaux, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Lincoln
Locations
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United Lincolnshire Hospitals NHS Trust
Lincoln, Lincolnshire, United Kingdom
Countries
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Other Identifiers
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120614Mullineaux
Identifier Type: -
Identifier Source: org_study_id
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