ClinicalTrials.gov
ClinicalTrials.gov Menu

Biomechanical Analysis of Dynamic Tasks and Muscular Strength Following Anterior Cruciate Ligament Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02771548
Recruitment Status : Recruiting
First Posted : May 13, 2016
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Sports Surgery Clinic Research Foundation
Insight Centre for Data Analytics
Science Foundation Ireland
University of Roehampton
University of Melbourne
University College Cork
University of Leeds
Children's Hospital Medical Center, Cincinnati
Information provided by (Responsible Party):
Sports Surgery Clinic, Santry, Dublin

Brief Summary:

Background

Anterior cruciate ligament (ACL) injuries are one of the most common sporting injuries of the knee. ACL reconstruction (ACLR) has become one of the most common surgical procedures in an attempt to increase joint stability and facilitate athletes to return to sport (RTS). Although ACLR is considered a relatively successful procedure, dynamic control risk factors and strength and power deficits in the involved limb are still present after patients return to sport.

Dynamic multi-plane, multi-joint actions such as jumping, landing, change of direction cutting, have been shown to be common mechanisms of injury for the ACL in field sports . Returning to multidirectional sports requires a proficiency and efficiency of movement when carrying out these tasks. There is a lack of standardized, objective criteria to accurately assess an athlete's ability to safely RTS. Therefore, there is a need for research that simultaneously analyses sport specific dynamic tasks (3D motion analysis) and muscular strength/power deficits that may explain poor outcomes following ACLR. This study aims to further investigate movement patterns, limb asymmetry and muscle strength deficit in patients post-surgery to identify risk factors for re-injury and criteria for RTS.

The purpose of this study was to:

  1. Analyse kinematic (movement descriptors) and kinetic (forces that cause movement) during sports specific dynamic tasks at different time-points (6 and 9 months) following ACLR.
  2. To explore the association of those findings with those who re-injure, those who have persistent knee pain or with those who fail to return to sport.
  3. To compare the ACLR participants with age and gender matched healthy multidirectional athletes.

It is hypothesised that biomechanical analysis will identify clear risk factors for poor outcomes following ACLR. Analysis of ACLR athletes' biomechanics during sports specific tasks will aid in the identification of athletes who are not yet ready to return to sport and will inform the clinician of what must be targeted in specific rehabilitation protocols before return to sport is considered.

Brief protocol

Participants will be recruited from patients who are scheduled to undergo anterior cruciate ligament reconstruction at the Sports Surgery Clinic, Ireland. Healthy participants will be recruited from local multidirectional teams. Participation will be voluntary and after obtaining informed consent patients will be asked to complete pre-operative questionnaires to ascertain injury information, and the function of their knee. During surgery the surgeon will fill out an intra-operative questionnaire. Items recorded will include graft type, laxity, involvement of other ligamentous structures, type of femoral and tibial fixation, meniscal or chondral pathology.

Biomechanical assessment takes place at 6 and 9 months post surgery for the ACL group while the healthy participants will be tested on one occasion. The 3D testing session will include capturing of jumping, landing, hopping and cutting mechanics through the use of three dimensional motion capture technology and force plates. Here reflective markers are placed on the skin at anatomical landmarks. These markers are picked up by the infrared cameras and tracked at 200 frames per second. Participants will make contact with a force plate with their foot on undertaking the movements. Force and marker data will be combined to calculate joint angles and moments. Participants will also perform a muscle strength test using equipment called an isokinetic dynamometer. Both the operated and non-operated limbs will be tested.

Participants will also be asked to fill out validated questionnaires to monitor self reported knee function, their confidence in their knee and also collect data on any continuing adverse symptoms such as locking, giving way, swelling or pain. Participants will also be asked if and when they return to sport. Questionnaires will be administered to participants at pre-op, 3, 6, 9, 12 and 24 months post operatively.


Condition or disease Intervention/treatment
Rupture of Anterior Cruciate Ligament Procedure: Anterior Cruciate Ligament Reconstruction

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Biomechanical Analysis of Dynamic Tasks and Muscular Strength Following Anterior Cruciate Ligament Reconstruction
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2040

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Anterior Cruciate Ligament Reconstruction
Those who have undergone unilateral anterior cruciate ligament reconstructive surgery in the Sports Surgery Clinic.
Procedure: Anterior Cruciate Ligament Reconstruction
Control
Healthy volunteers with no previous knee injury, no current lower limb injuries and take part in regular multidirectional team sports.



Primary Outcome Measures :
  1. Return to Performance- change in status [ Time Frame: 6,9,12 and 24 months post operatively ]
    The Sports Surgery Clinic return to performance questionnaire asks whether the participant has returned to sport.

  2. Injured operated knee- change in status [ Time Frame: 6,9,12 and 24 months post operatively ]
    Participants are asked have they injured their operated knee.

  3. Injured their contralateral knee- change in status [ Time Frame: 6,9,12 and 24 months post operatively ]
    Participants are asked have they injured their operated knee.

  4. Change in pain experienced [ Time Frame: 6,9,12 and 24 months post operatively ]
    Participants will be asked to rate their pain on a numerical rating scale, 0-10.


Secondary Outcome Measures :
  1. Change in Kinetic and kinematic composite score of the lower limb, pelvis and trunk [ Time Frame: At 6 and 9 months post surgery ]
    Associations can be made between post surgical change in biomechanical variables exhibited on sports specific tasks and poor outcomes following ACLR.

  2. Change in International Knee Documentation Committee (IKDC) [ Time Frame: 3, 6, 9, 12 and 24 months post surgery ]
    The IKDC subjective form is a reliable and valid measure to monitor symptoms and function in daily living activities in those with knee disorders (Higgins et al. 2007).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Those who undergo anterior cruciate ligament reconstruction in the Sports Surgery Clinic, Dublin, and who meet the inclusion criteria, will be asked if they wish to participate in this study. Sports Surgery Clinic is a private hospital where over 750 ACL reconstructive surgeries take place each year. Many patients will travel from all over the country of Ireland to the clinic for the surgery, meaning there is a wide catchment area for participants.
Criteria

Inclusion Criteria:

  • Active participants
  • Anterior cruciate ligament reconstruction surgery in the Sports Surgery Clinic.
  • Over the age of 13 years

Exclusion Criteria:

  • Multiple orthopaedic injuries concurrently.
  • Surgery outside of Sports Surgery Clinic.

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): NCT02771548


Contacts
Contact: Andrew D Franklyn-Miller, MBBS MRCGP FFSEM 00 353 1 526 2030 afranklynmiller@me.com
Contact: Enda King, MSc 00 353 1 526 2040 endaking@hotmail.com

Locations
Ireland
Sports Surgery Clinic Recruiting
Dublin, Leinster, Ireland
Contact: Andy D Franklyn-Miller, MBBS    00 353 1 526 2030    afranklynmiller@me.com   
Contact: Enda A King, BSc, MSc    00 353 1 526 2030    endaking@sportssurgeryclinic.com   
Sponsors and Collaborators
Sports Surgery Clinic, Santry, Dublin
Sports Surgery Clinic Research Foundation
Insight Centre for Data Analytics
Science Foundation Ireland
University of Roehampton
University of Melbourne
University College Cork
University of Leeds
Children's Hospital Medical Center, Cincinnati
Investigators
Study Director: Ray Moran, MCh (Orth) FRCSI FFSEM Sports Surgery Clinic
Study Director: Mark Jackson, MBBS BSc FRCS Sports Surgery Clinic
Principal Investigator: Enda King, MSc Sports Surgery Clinic

Publications:

Responsible Party: Sports Surgery Clinic, Santry, Dublin
ClinicalTrials.gov Identifier: NCT02771548     History of Changes
Other Study ID Numbers: SSC-ACL-001
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Sports Surgery Clinic, Santry, Dublin:
Knee injuries
Rehabilitation
Return to sport
Biomechanics

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