NCT02771548

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. 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. 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. 3.To compare the ACLR participants with age and gender matched healthy multidirectional athletes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
178mo left

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2014Dec 2040

Study Start

First participant enrolled

January 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
24.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2040

Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

26.9 years

First QC Date

February 5, 2016

Last Update Submit

April 18, 2024

Conditions

Keywords

Knee injuriesRehabilitationReturn to sportBiomechanics

Outcome Measures

Primary Outcomes (4)

  • Return to Performance- change in status

    The Sports Surgery Clinic return to performance questionnaire asks whether the participant has returned to sport.

    6,9,12 and 24 months post operatively

  • Injured operated knee- change in status

    Participants are asked have they injured their operated knee.

    6,9,12 and 24 months post operatively

  • Injured their contralateral knee- change in status

    Participants are asked have they injured their operated knee.

    6,9,12 and 24 months post operatively

  • Change in pain experienced

    Participants will be asked to rate their pain on a numerical rating scale, 0-10.

    6,9,12 and 24 months post operatively

Secondary Outcomes (2)

  • Change in Kinetic and kinematic composite score of the lower limb, pelvis and trunk

    At 6 and 9 months post surgery

  • Change in International Knee Documentation Committee (IKDC)

    3, 6, 9, 12 and 24 months post surgery

Study Arms (2)

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.

Interventions

Anterior Cruciate Ligament Reconstruction

Eligibility Criteria

Age13 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Surgery Clinic

Dublin, Leinster, Ireland

RECRUITING

Related Publications (12)

  • Boden BP, Griffin LY, Garrett WE Jr. Etiology and Prevention of Noncontact ACL Injury. Phys Sportsmed. 2000 Apr;28(4):53-60. doi: 10.3810/psm.2000.04.841.

    PMID: 20086634BACKGROUND
  • Koga H, Nakamae A, Shima Y, Iwasa J, Myklebust G, Engebretsen L, Bahr R, Krosshaug T. Mechanisms for noncontact anterior cruciate ligament injuries: knee joint kinematics in 10 injury situations from female team handball and basketball. Am J Sports Med. 2010 Nov;38(11):2218-25. doi: 10.1177/0363546510373570. Epub 2010 Jul 1.

    PMID: 20595545BACKGROUND
  • Higgins LD, Taylor MK, Park D, Ghodadra N, Marchant M, Pietrobon R, Cook C; International Knee Documentation Committee. Reliability and validity of the International Knee Documentation Committee (IKDC) Subjective Knee Form. Joint Bone Spine. 2007 Dec;74(6):594-9. doi: 10.1016/j.jbspin.2007.01.036. Epub 2007 Aug 6.

    PMID: 17888709BACKGROUND
  • Marx RG, Stump TJ, Jones EC, Wickiewicz TL, Warren RF. Development and evaluation of an activity rating scale for disorders of the knee. Am J Sports Med. 2001 Mar-Apr;29(2):213-8. doi: 10.1177/03635465010290021601.

    PMID: 11292048BACKGROUND
  • Webster KE, Feller JA, Lambros C. Development and preliminary validation of a scale to measure the psychological impact of returning to sport following anterior cruciate ligament reconstruction surgery. Phys Ther Sport. 2008 Feb;9(1):9-15. doi: 10.1016/j.ptsp.2007.09.003. Epub 2007 Nov 5.

    PMID: 19083699BACKGROUND
  • Barber-Westin SD, Noyes FR, McCloskey JW. Rigorous statistical reliability, validity, and responsiveness testing of the Cincinnati knee rating system in 350 subjects with uninjured, injured, or anterior cruciate ligament-reconstructed knees. Am J Sports Med. 1999 Jul-Aug;27(4):402-16. doi: 10.1177/03635465990270040201.

    PMID: 10424208BACKGROUND
  • Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Myer GD, Huang B, Hewett TE. Biomechanical measures during landing and postural stability predict second anterior cruciate ligament injury after anterior cruciate ligament reconstruction and return to sport. Am J Sports Med. 2010 Oct;38(10):1968-78. doi: 10.1177/0363546510376053. Epub 2010 Aug 11.

    PMID: 20702858BACKGROUND
  • McAleese T, Welch N, King E, Roshan D, Keane N, Moran KA, Jackson M, Withers D, Moran R, Devitt BM. Primary Anterior Cruciate Ligament Reconstruction in Level 1 Athletes: Factors Associated With Return to Play, Reinjury, and Knee Function at 5 Years of Follow-up. Am J Sports Med. 2025 Mar;53(4):777-790. doi: 10.1177/03635465241313386. Epub 2025 Feb 7.

  • King E, Richter C, Daniels KAJ, Franklyn-Miller A, Falvey E, Myer GD, Jackson M, Moran R, Strike S. Biomechanical but Not Strength or Performance Measures Differentiate Male Athletes Who Experience ACL Reinjury on Return to Level 1 Sports. Am J Sports Med. 2021 Mar;49(4):918-927. doi: 10.1177/0363546520988018. Epub 2021 Feb 22.

  • King E, Richter C, Daniels KAJ, Franklyn-Miller A, Falvey E, Myer GD, Jackson M, Moran R, Strike S. Can Biomechanical Testing After Anterior Cruciate Ligament Reconstruction Identify Athletes at Risk for Subsequent ACL Injury to the Contralateral Uninjured Limb? Am J Sports Med. 2021 Mar;49(3):609-619. doi: 10.1177/0363546520985283. Epub 2021 Feb 9.

  • King E, Richter C, Jackson M, Franklyn-Miller A, Falvey E, Myer GD, Strike S, Withers D, Moran R. Factors Influencing Return to Play and Second Anterior Cruciate Ligament Injury Rates in Level 1 Athletes After Primary Anterior Cruciate Ligament Reconstruction: 2-Year Follow-up on 1432 Reconstructions at a Single Center. Am J Sports Med. 2020 Mar;48(4):812-824. doi: 10.1177/0363546519900170. Epub 2020 Feb 7.

  • King E, Richter C, Franklyn-Miller A, Wadey R, Moran R, Strike S. Back to Normal Symmetry? Biomechanical Variables Remain More Asymmetrical Than Normal During Jump and Change-of-Direction Testing 9 Months After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2019 Apr;47(5):1175-1185. doi: 10.1177/0363546519830656.

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Ray Moran, MCh (Orth) FRCSI FFSEM

    Sports Surgery Clinic

    STUDY DIRECTOR
  • Mark Jackson, MBBS BSc FRCS

    Sports Surgery Clinic

    STUDY DIRECTOR

Central Study Contacts

Neil B Welch, PhD

CONTACT

Thilina Vitherana, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of lab services and research

Study Record Dates

First Submitted

February 5, 2016

First Posted

May 13, 2016

Study Start

January 1, 2014

Primary Completion (Estimated)

December 1, 2040

Study Completion (Estimated)

December 1, 2040

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations