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

NCT02300012 | Completed

• 1 other identifier: 120614Mullineaux
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Anterior cruciate ligament; Performance based investigations

Outcome Measures

Primary Outcomes (8)

• 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

• 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 time taken to complete a sit-to-stand task, from baseline to 6 months post-ACL reconstruction

  Baseline, 6 months

Secondary Outcomes (5)

• 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 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

Study Arms (4)

Operation - No PBI

NO INTERVENTION

Patients requiring operation - baseline PBI data not seen by surgeon

Operation - PBI available

EXPERIMENTAL

Patients requiring operation - baseline PBI data seen by surgeon pre-operatively

Procedure: Surgeons knowledge of pre-operative PBIs

Non-operation

NO INTERVENTION

Patients with ACL rupture not requiring operation

Control

NO INTERVENTION

Healthy age matched volunteers - No operation

Interventions

Surgeons knowledge of pre-operative PBIs PROCEDURE

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

Operation - PBI available

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• unilateral ACL rupture
• years old

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Lincolnshire Hospitals NHS Trust: lead
• University of Lincoln: collaborator

Study Sites (1)

United Lincolnshire Hospitals NHS Trust

Lincoln, Lincolnshire, LN2 5QY, United Kingdom

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Prof David Mullineaux, PhD

  University of Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 24, 2014
• Study Start: January 5, 2015
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

GB (1)