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

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surgeons knowledge of pre-operative PBIs
Sponsored by
United Lincolnshire Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rupture of Anterior Cruciate Ligament focused on measuring Anterior cruciate ligament, Performance based investigations

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • United Lincolnshire Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

No Intervention

Arm Label

Operation - No PBI

Operation - PBI available

Non-operation

Control

Arm Description

Patients requiring operation - baseline PBI data not seen by surgeon

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

Patients with ACL rupture not requiring operation

Healthy age matched volunteers - No operation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction
The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction
The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction
The change in International Knee Documentation Committee subjective knee evaluation form from 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

Full Information

First Posted
October 23, 2014
Last Updated
May 23, 2022
Sponsor
United Lincolnshire Hospitals NHS Trust
Collaborators
University of Lincoln
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1. Study Identification

Unique Protocol Identification Number
NCT02300012
Brief Title
A Pilot Study to Investigate Biomarkers in Anterior Cruciate Ligament (ACL) Patients and Healthy Controls
Official Title
A Pilot Study to Investigate Biomarkers in ACL Patients and Healthy Controls
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2015 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
May 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Lincolnshire Hospitals NHS Trust
Collaborators
University of Lincoln

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament
Keywords
Anterior cruciate ligament, Performance based investigations

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Operation - No PBI
Arm Type
No Intervention
Arm Description
Patients requiring operation - baseline PBI data not seen by surgeon
Arm Title
Operation - PBI available
Arm Type
Experimental
Arm Description
Patients requiring operation - baseline PBI data seen by surgeon pre-operatively
Arm Title
Non-operation
Arm Type
No Intervention
Arm Description
Patients with ACL rupture not requiring operation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy age matched volunteers - No operation
Intervention Type
Procedure
Intervention Name(s)
Surgeons knowledge of pre-operative PBIs
Intervention Description
Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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 Measure Information:
Title
The change in Interleukin-6 obtained from blood samples at baseline to 6 months post-ACL reconstruction
Time Frame
6 months post-ACL reconstruction
Title
The change in Tegner Activity Score from baseline to 6 months post-ACL reconstruction
Time Frame
6 months post-ACL reconstruction
Title
The change in Lysholm Knee Scoring Scale from baseline to 6 months post-ACL reconstruction
Time Frame
6 months post-ACL reconstruction
Title
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
Title
The difference in bone morphogenetic protein-7 (BMP-7) between smokers and non-smokers who undergo ACL reconstruction
Time Frame
At time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof David Mullineaux, PhD
Organizational Affiliation
University of Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Lincolnshire Hospitals NHS Trust
City
Lincoln
State/Province
Lincolnshire
ZIP/Postal Code
LN2 5QY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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