An interventional study of Surgeons knowledge of pre-operative PBIs in Rupture of Anterior Cruciate Ligament, sponsored by United Lincolnshire Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by United Lincolnshire Hospitals NHS Trust · Not applicable, Interventional, and Supportive care
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 8 is below the median of 72 across 334 interventional studies indexed under Rupture.
Browse Rupture studies →United Lincolnshire Hospitals NHS Trust is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients requiring operation - baseline PBI data not seen by surgeon
Patients requiring operation - baseline PBI data seen by surgeon pre-operatively
Procedure: Surgeons knowledge of pre-operative PBIs
Patients with ACL rupture not requiring operation
Healthy age matched volunteers - No operation
Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice
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
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
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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United Lincolnshire Hospitals NHS Trust