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

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

A Pilot Study to Investigate Biomarkers in ACL Patients and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300012
• Other study ID #: 120614Mullineaux
• Status: Completed
• Phase: N/A
• Start date: January 5, 2015
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2022
• Source: United Lincolnshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rupture
• Rupture of Anterior Cruciate Ligament

Intervention

Procedure:
• Surgeons knowledge of pre-operative PBIs
Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice

Locations

Country	Name	City	State
United Kingdom	United Lincolnshire Hospitals NHS Trust	Lincoln	Lincolnshire

Sponsors (2)

Lead Sponsor	Collaborator
United Lincolnshire Hospitals NHS Trust	University of Lincoln

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in knee varus/valgus from baseline to 6 weeks post-ACL reconstruction, measured when performing a single leg squat.		Baseline, 6 weeks
Primary	The change in knee varus/valgus from baseline to 6 months post-ACL reconstruction, measured when performing a single leg squat		Baseline, 6 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	The change in time taken to complete a sit-to-stand task, from baseline to 6 weeks post-ACL reconstruction		Baseline, 6 weeks
Primary	The change in time taken to complete a sit-to-stand task, from baseline to 6 months post-ACL reconstruction		Baseline, 6 months
Secondary	The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction		6 months post-ACL reconstruction
Secondary	The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction		6 months post-ACL reconstruction
Secondary	The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction		6 months post-ACL reconstruction
Secondary	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
Secondary	The difference in bone morphogenetic protein-7 (BMP-7) between smokers and non-smokers who undergo ACL reconstruction		At time of surgery