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NCT Number: NCT02300012

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

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.

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Key information

Conditions

Rupture of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

United Lincolnshire Hospitals NHS Trust

Lincoln, Lincolnshire, LN2 5QY, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgeons knowledge of pre-operative PBIs

Procedure

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction

    Time frame: 6 months post-ACL reconstruction

  2. The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction

    Time frame: 6 months post-ACL reconstruction

  3. The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction

    Time frame: 6 months post-ACL reconstruction

  4. 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

  5. The difference in bone morphogenetic protein-7 (BMP-7) between smokers and non-smokers who undergo ACL reconstruction

    Time frame: At time of surgery

Sponsors and collaborators

Lead sponsor

United Lincolnshire Hospitals NHS Trust

Other

Collaborators

  • University of Lincoln

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2014
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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