NCT02686723

Brief Summary

Comparison of two groups of subjets (ACL injury who return to sport) and control group non-injured about clinical and biomechanical data :

  • clinical test
  • functional test
  • motion analysis of 2 sport exercises
  • tibial translation
  • isokinetic evaluation

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 17, 2020

Status Verified

January 1, 2020

Enrollment Period

10 months

First QC Date

February 10, 2016

Last Update Submit

March 13, 2020

Conditions

ACL Injury

Keywords

ACL injuryReturn to sportMotion analysisIsokinetic evaluationRisk factor

Outcome Measures

Primary Outcomes (1)

  • Limb Symmetry Index

    Day 0

Study Arms (2)

ACL injury

EXPERIMENTAL

Subjects who has ACL injury repaired and who were allowed to return to sport

Other: Clinical and biomechanical evaluations

Healthy subjects

ACTIVE COMPARATOR

Subjects who has never been injured in ACL and who practice sports with cutting task (soccer, handball)

Other: Clinical and biomechanical evaluations

Interventions

Clinical and biomechanical evaluationsOTHER

Clinical evaluation : demographics, clinic and functional testing. Biomechanical evaluation : isokinetic, motion analysis of 2 specific motion (drop vertical jump and cutting task) and anterior tibial translation with GnRB

ACL injuryHealthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgeon repair ACL injury ; sport practice ; signed informed consent

You may not qualify if:

  • for injury subjects: pain during cutting tasks ; associated injury with ACL rupture
  • for healthy subjects: history of ACL injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Brest, 29200, France

Location

Related Publications (8)

  • Granan LP, Bahr R, Steindal K, Furnes O, Engebretsen L. Development of a national cruciate ligament surgery registry: the Norwegian National Knee Ligament Registry. Am J Sports Med. 2008 Feb;36(2):308-15. doi: 10.1177/0363546507308939. Epub 2007 Nov 7.

    PMID: 17989167BACKGROUND

  • Olsen OE, Myklebust G, Engebretsen L, Bahr R. Injury mechanisms for anterior cruciate ligament injuries in team handball: a systematic video analysis. Am J Sports Med. 2004 Jun;32(4):1002-12. doi: 10.1177/0363546503261724.

    PMID: 15150050BACKGROUND

  • Herbst E, Hoser C, Hildebrandt C, Raschner C, Hepperger C, Pointner H, Fink C. Functional assessments for decision-making regarding return to sports following ACL reconstruction. Part II: clinical application of a new test battery. Knee Surg Sports Traumatol Arthrosc. 2015 May;23(5):1283-1291. doi: 10.1007/s00167-015-3546-3. Epub 2015 Feb 28.

    PMID: 25724802BACKGROUND

  • Crawford SN, Waterman BR, Lubowitz JH. Long-term failure of anterior cruciate ligament reconstruction. Arthroscopy. 2013 Sep;29(9):1566-71. doi: 10.1016/j.arthro.2013.04.014. Epub 2013 Jun 29.

    PMID: 23820260BACKGROUND

  • Webster KE, Feller JA, Leigh WB, Richmond AK. Younger patients are at increased risk for graft rupture and contralateral injury after anterior cruciate ligament reconstruction. Am J Sports Med. 2014 Mar;42(3):641-7. doi: 10.1177/0363546513517540. Epub 2014 Jan 22.

    PMID: 24451111BACKGROUND

  • Ford KR, Myer GD, Hewett TE. Valgus knee motion during landing in high school female and male basketball players. Med Sci Sports Exerc. 2003 Oct;35(10):1745-50. doi: 10.1249/01.MSS.0000089346.85744.D9.

    PMID: 14523314BACKGROUND

  • Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.

    PMID: 15722287BACKGROUND

  • 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

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Olivier REMY-NERIS, MD, PhD

    University Hospital Brest, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 19, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 17, 2020

Record last verified: 2020-01

Locations

FR(1)