Anterior Cruciate Ligament RuptureLAXIMETRIENCT02875210
Comparative Study of Anterior Tibial Translation Measurement by Four Laximeters in Anterior Cruciate Ligament Ruptures
A study testing Laximeter measurement in people with Anterior Cruciate Ligament Rupture, run by Versailles Hospital at 1 site in France.
Trial summary
Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Laximeter measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2015to Jun 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obtaining a written informed consent of the patient,
- Affiliated with a Medicare (or rightful beneficiary),
- Disponibility of the patient,
- Patients ≥ 18 ans,
- Anterior cruciate ligament rupture concerned only one knee of the patient.
Who cannot join
- Patient is in the exclusion period for another study,
- Patient is under judicial protection, guardianship, or curators,
- Eligible patients who are refused to sign consent,
- It is impossible to give clear informations to the patient,
- Pregnant women,
- Nursing mother,
- Patient which has been already operate of the other knee,
- Patient present ligament lesions associated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures
Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. The aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Laximeter measurement
- Keywords
- Anterior Cruciate Ligament, A02.835.583.512.100
- 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.
Laximeter measurementProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patient with anterior cruciate ligament rupture | Experimental | Anterior laxity of patient was measure with 4 laximeters:Telos, reference laximeter and with three other instruments called, KT-1000, GnrB and Rolimeter. Receives: Procedure: Laximeter measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of anterior laxity measurement between pathologic and healthy knees.
Collect and compare differential values of anterior laxity between pathologic and healthy knee obtained by four different laximeters (Telos, KT-1000, GnrB and Rolimeter)
Measured: 18 months
Secondary outcomes (3)
Sensivity and specificity of each instrument
Determine sensivity and specificity of each instrument test to highlight a cruciate ligament rupture and find the better test.
Evaluations are using the 4 following devices: Telos ©, KT-1000 ©, Rolimeter, and GnrB.
Measured: 18 months
Correlation between the f4 laximeters results
Estimate if correlation between two results increase discriminating capacity in comparison with the reference.
Measured: 18 months
Value of the ratio : pathologic (anterior knee laxity) versus healthy knee
Compare ratio pathologic versus healthy knee obtained with each instrument to determine a possible harmonization of measurements
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startJul 2015
- Primary completionJan 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Pujol, Versailles Hospital
- Investigators
- Nicolas PUJOL, MD, Principal investigator, Central Hospital of Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875210
- Sponsor's protocol ID
- P15/02_LAXIMETRIE
- Acronym
- LAXIMETRIE
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Anterior Tibial Translation Measurement by Four Different Laximeters in Anterior Cruciate Ligament Ruptures
- ClinicalTrials.gov ID
- NCT02875210
- Acronym / sponsor ID
- LAXIMETRIE / P15/02_LAXIMETRIE
- Conditions
- Anterior Cruciate Ligament Rupture
- Keywords
- Anterior Cruciate Ligament, A02.835.583.512.100
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 23 Aug 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.
Actually, there are several laximeters for measuring anterior tibial translational in case of anterior cruciate ligament rupture. The most commonly used are telos, KT-1000, GnrB and Rolimeter. Results of these instrumented tests, which expressed in differential (millimeters values), have a bad correlation between them and so are not comparable in current literature. The aim of this study was to compare results of these tests and establish a ratio (pathologic knee laxity/ healthy knee laxity) to reduce differences between each instrumented test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with anterior cruciate ligament rupture | Experimental | Procedure: Laximeter measurementAnterior laxity of patient was measure with 4 laximeters:Telos, reference laximeter and with three other instruments called, KT-1000, GnrB and Rolimeter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Obtaining a written informed consent of the patient,
- Affiliated with a Medicare (or rightful beneficiary),
- Disponibility of the patient,
- Patients ≥ 18 ans,
- Anterior cruciate ligament rupture concerned only one knee of the patient.
Key exclusion criteria (8 listed)
- Patient is in the exclusion period for another study,
- Patient is under judicial protection, guardianship, or curators,
- Eligible patients who are refused to sign consent,
- It is impossible to give clear informations to the patient,
- Pregnant women,
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 |
|---|---|---|
| Laximeter measurement | Procedure or surgery | Patient with anterior cruciate ligament rupture |
Primary outcome
Comparison of anterior laxity measurement between pathologic and healthy knees.
Time frame: 18 months
Collect and compare differential values of anterior laxity between pathologic and healthy knee obtained by four different laximeters (Telos, KT-1000, GnrB and Rolimeter)
3 secondary outcomes
Sensivity and specificity of each instrument
Time frame: 18 months
Correlation between the f4 laximeters results
Time frame: 18 months
Value of the ratio : pathologic (anterior knee laxity) versus healthy knee
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Anterior Cruciate Ligament Rupture
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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.
Nicolas PUJOL, MD principal investigator
Central Hospital of Versailles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laximeter measurement in people with Anterior Cruciate Ligament Rupture, run by Versailles Hospital 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Aug 2016. 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?
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?
Comparison of anterior laxity measurement between pathologic and healthy knees. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2016.