ACL InjuryREPILOGNCT02686723
Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury
A study testing Clinical and biomechanical evaluations in people with ACL Injury, run by University Hospital, Brest at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- ACL Injury
- What is being tested?
- Clinical and biomechanical evaluations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- surgeon repair ACL injury ; sport practice ; signed informed consent
Who cannot join
- for injury subjects: pain during cutting tasks ; associated injury with ACL rupture
- for healthy subjects: history of ACL injury
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- ACL Injury
- Being tested
- Clinical and biomechanical evaluations
- Keywords
- ACL injury, Return to sport, Motion analysis, Isokinetic evaluation, Risk factor
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ACL injury | Experimental | Subjects who has ACL injury repaired and who were allowed to return to sport Receives: 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) Receives: Other: Clinical and biomechanical evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb Symmetry Index
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier REMY-NERIS, MD, PhD, Principal investigator, University Hospital Brest, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02686723
- Sponsor's protocol ID
- RB15.162
- Acronym
- REPILOG
- Status last verified
- Jan 2020
- First submitted
- 10 Feb 2016
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17989167Olsen 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.
PubMed 15150050Herbst 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.
PubMed 25724802Crawford 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.
PubMed 23820260Webster 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.
PubMed 24451111Ford 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.
PubMed 14523314Hewett 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.
PubMed 15722287Paterno 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.
PubMed 20702858
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Biomechanical Correlation During Return to Sport After Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT02686723
- Acronym / sponsor ID
- REPILOG / RB15.162
- Conditions
- ACL Injury
- Keywords
- ACL injury, Return to sport, Motion analysis, Isokinetic evaluation, Risk factor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL injury | Experimental | Other: Clinical and biomechanical evaluationsSubjects who has ACL injury repaired and who were allowed to return to sport |
| Healthy subjects | Active comparator | Other: Clinical and biomechanical evaluationsSubjects who has never been injured in ACL and who practice sports with cutting task (soccer, handball) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- surgeon repair ACL injury ; sport practice ; signed informed consent
Key exclusion criteria (2 listed)
- for injury subjects: pain during cutting tasks ; associated injury with ACL rupture
- for healthy subjects: history of ACL injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and biomechanical evaluationsClinical 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 | Other | ACL injury, Healthy subjects |
Primary outcome
Limb Symmetry Index
Time frame: Day 0
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 17989167Granan 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.
- Background: PubMed 15150050Olsen 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.
- Background: PubMed 25724802Herbst 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.
- Background: PubMed 23820260Crawford 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.
- Background: PubMed 24451111Webster 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.
- Background: PubMed 14523314Ford 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.
- Background: PubMed 15722287Hewett 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.
- Background: PubMed 20702858Paterno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier REMY-NERIS, MD, PhD principal investigator
University Hospital Brest, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and biomechanical evaluations in people with ACL Injury, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb Symmetry Index (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02686723, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.