Back to resultsEvaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury (REPILOG)
Primary Purpose
ACL Injury
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical and biomechanical evaluations
Sponsored by
About this trial
This is an interventional diagnostic trial for ACL Injury focused on measuring ACL injury, Return to sport, Motion analysis, Isokinetic evaluation, Risk factor
Eligibility Criteria
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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ACL injury
Healthy subjects
Arm Description
Subjects who has ACL injury repaired and who were allowed to return to sport
Subjects who has never been injured in ACL and who practice sports with cutting task (soccer, handball)
Outcomes
Primary Outcome Measures
Limb Symmetry Index
Secondary Outcome Measures
Full Information
NCT ID
NCT02686723
First Posted
February 10, 2016
Last Updated
March 13, 2020
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02686723
Brief Title
Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury
Acronym
REPILOG
Official Title
Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
ACL injury, Return to sport, Motion analysis, Isokinetic evaluation, Risk factor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACL injury
Arm Type
Experimental
Arm Description
Subjects who has ACL injury repaired and who were allowed to return to sport
Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
Subjects who has never been injured in ACL and who practice sports with cutting task (soccer, handball)
Intervention Type
Other
Intervention Name(s)
Clinical and biomechanical evaluations
Intervention Description
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
Primary Outcome Measure Information:
Title
Limb Symmetry Index
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier REMY-NERIS, MD, PhD
Organizational Affiliation
University Hospital Brest, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Brest
ZIP/Postal Code
29200
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17989167
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. doi: 10.1177/0363546507308939. Epub 2007 Nov 7.
Results Reference
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PubMed Identifier
15150050
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. doi: 10.1177/0363546503261724.
Results Reference
background
PubMed Identifier
25724802
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.
Results Reference
background
PubMed Identifier
23820260
Citation
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.
Results Reference
background
PubMed Identifier
24451111
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.
Results Reference
background
PubMed Identifier
14523314
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. doi: 10.1249/01.MSS.0000089346.85744.D9.
Results Reference
background
PubMed Identifier
15722287
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. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.
Results Reference
background
PubMed Identifier
20702858
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.
Results Reference
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Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury
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