Rupture of Anterior Cruciate Ligament
Conditions
Keywords
Anterior cruciate ligament, Performance based investigations
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.
Interventions
PROCEDURESurgeons knowledge of pre-operative PBIs
Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice
Sponsors
University of Lincoln
United Lincolnshire Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in time taken to complete a sit-to-stand task, from baseline to 6 months post-ACL reconstruction | 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. | 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. | 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. | 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. | Baseline, 6 months |
| The change in time taken to complete a sit-to-stand task, from baseline to 6 weeks post-ACL reconstruction | Baseline, 6 weeks |
| The change in knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat. | Baseline, 6 weeks |
| The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat | Baseline, 6 months |
Secondary
| Measure | Time frame |
|---|---|
| The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction | 6 months post-ACL reconstruction |
| The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction | 6 months post-ACL reconstruction |
| The change in International Knee Documentation Committee subjective knee evaluation form from baseline to 6 months post-ACL reconstruction | 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 | At time of surgery |
| The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction | 6 months post-ACL reconstruction |
Countries
United Kingdom
Outcome results
None listed