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

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ClinicalTrials.gov Identifier: NCT02300012
Recruitment Status : Unknown
Verified December 2015 by United Lincolnshire Hospitals NHS Trust.
Recruitment status was:  Recruiting
First Posted : November 24, 2014
Last Update Posted : December 15, 2015
Sponsor:
Collaborator:
University of Lincoln
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Rupture of Anterior Cruciate Ligament Procedure: Surgeons knowledge of pre-operative PBIs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study to Investigate Biomarkers in ACL Patients and Healthy Controls
Study Start Date : February 2015
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2016

Arm Intervention/treatment
No Intervention: Operation - No PBI
Patients requiring operation - baseline PBI data not seen by surgeon
Experimental: Operation - PBI available
Patients requiring operation - baseline PBI data seen by surgeon pre-operatively
Procedure: Surgeons knowledge of pre-operative PBIs
Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice

No Intervention: Non-operation
Patients with ACL rupture not requiring operation
No Intervention: Control
Healthy age matched volunteers - No operation



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300012


Contacts
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Contact: Prof David Mullineaux, PhD +44 1522 837143 dmullineaux@lincoln.ac.uk

Locations
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United Kingdom
United Lincolnshire Hospitals NHS Trust Recruiting
Lincoln, Lincolnshire, United Kingdom, LN2 5QY
Sponsors and Collaborators
United Lincolnshire Hospitals NHS Trust
University of Lincoln
Investigators
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Principal Investigator: Prof David Mullineaux, PhD University of Lincoln

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Responsible Party: United Lincolnshire Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02300012     History of Changes
Other Study ID Numbers: 120614Mullineaux
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by United Lincolnshire Hospitals NHS Trust:
Anterior cruciate ligament
Performance based investigations

Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries