A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls

Not Applicable

Completed

• Conditions: Rupture of Anterior Cruciate Ligament
• Interventions: Procedure: Surgeons knowledge of pre-operative PBIs

• Registration Number: NCT02300012
• Lead Sponsor: United Lincolnshire Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Study Start: 2015-01-05
• Status Verified: 2022-05
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-20
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operation - PBI available	Surgeons knowledge of pre-operative PBIs	Patients requiring operation - baseline PBI data seen by surgeon pre-operatively

Primary Outcome Measures

Name	Time	Method
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 knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat.	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 months post-ACL reconstruction	Baseline, 6 months
The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat	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 time taken to complete a sit-to-stand task, from baseline to 6 weeks post-ACL reconstruction	Baseline, 6 weeks

Secondary Outcome Measures

Name	Time	Method
The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction	6 months post-ACL reconstruction
The change in Tegner Activity Score 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 change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction	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

Trial Locations

Locations (1)

United Lincolnshire Hospitals NHS Trust; 🇬🇧 Lincoln, Lincolnshire, United Kingdom