Clinical trial NCT02300012: A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls
Official title: A Pilot Study to Investigate Biomarkers in ACL Patients and Healthy Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: Anterior cruciate ligament
Performance based investigations
Lead sponsor: United Lincolnshire Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Lincoln
First posted: 2014-11-24
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* unilateral ACL rupture
* 18 - 45 years old

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The change in knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat.
timeFrame: Baseline, 6 weeks
measure: The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat
timeFrame: Baseline, 6 months
measure: 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.
timeFrame: Baseline, 6 weeks
measure: 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.
timeFrame: Baseline, 6 months
measure: 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.
timeFrame: Baseline, 6 weeks
measure: 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.
timeFrame: Baseline, 6 months
measure: The change in time taken to complete a sit-to-stand task, from baseline to 6 weeks post-ACL reconstruction
timeFrame: Baseline, 6 weeks
measure: The change in time taken to complete a sit-to-stand task, from baseline to 6 months post-ACL reconstruction
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction
timeFrame: 6 months post-ACL reconstruction
measure: The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction
timeFrame: 6 months post-ACL reconstruction
measure: The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction
timeFrame: 6 months post-ACL reconstruction
measure: The change in International Knee Documentation Committee subjective knee evaluation form from baseline to 6 months post-ACL reconstruction
timeFrame: baseline to 6 months post-ACL reconstruction
measure: The difference in bone morphogenetic protein-7 (BMP-7) between smokers and non-smokers who undergo ACL reconstruction
timeFrame: At time of surgery
Other outcomes:
Locations:
city: Lincoln
country: United Kingdom
facility: United Lincolnshire Hospitals NHS Trust
state: Lincolnshire
Study officials:
affiliation: University of Lincoln
name: Prof David Mullineaux, PhD
role: PRINCIPAL_INVESTIGATOR
References: