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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02686723
Other study ID # RB15.162
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date December 2016

Study information

Verified date January 2020
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

ACL injury in sport practice is frequent and after surgery subjects want to return to sport. Re injury during return to sport is significant and clinical and biomechanical risk factors are described. But no study investigate link between clinical and biomechanical during this risk period.

The study will search to highlight correlation between clinical and biomechanical factors. Investigators will realize clinical evaluation (pain, translation) and functional tests (single hop test, triple hop test, 6m time hop test, crossover test). For biomechanical data, investigators will test 2 exercises in motion analyse laboratory (drop vertical jump and cutting task), a translation knee test with GnRB and isokinetic evaluation.

Investigators will compared results of injured subjects with a control group non-injured.


Recruitment information / eligibility

Status Terminated
Enrollment 27
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- for injury subjects: pain during cutting tasks ; associated injury with ACL rupture

- for healthy subjects: history of ACL injury

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Clinical and biomechanical evaluations
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

Locations

Country Name City State
France University Hospital Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. Epub 2007 Nov 7. — View Citation

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):1283-91. doi: 10.1007/s00167-015-3546-3. Epub 2015 Feb 28. — View Citation

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. Epub 2005 Feb 8. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Limb Symmetry Index Day 0
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