Comparative Study of Anterior Tibial Translation Measurement by Four Laximeters in Anterior Cruciate Ligament Ruptures
LAXIMETRIE
1 other identifier
interventional
43
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 11, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 23, 2016
August 1, 2016
1.5 years
August 11, 2016
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
18 months
Secondary Outcomes (3)
Sensivity and specificity of each instrument
18 months
Correlation between the f4 laximeters results
18 months
Value of the ratio : pathologic (anterior knee laxity) versus healthy knee
18 months
Study Arms (1)
Patient with anterior cruciate ligament rupture
EXPERIMENTALAnterior laxity of patient was measure with 4 laximeters:Telos, reference laximeter and with three other instruments called, KT-1000, GnrB and Rolimeter.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier de Versailles
Le Chesnay, 78150, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas PUJOL, MD
Central Hospital of Versailles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator coordinator
Study Record Dates
First Submitted
August 11, 2016
First Posted
August 23, 2016
Study Start
July 1, 2015
Primary Completion
January 1, 2017
Study Completion
June 1, 2017
Last Updated
August 23, 2016
Record last verified: 2016-08