Clinical trial NCT02567058: Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)
Official title: Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alterations of the Achilles Tendon
Keywords: Achilles tendon
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Among Musculoskeletal disorders (MSD) the rupture of the Achilles tendon is the most common. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity.

The laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps.

This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.

Detailed description: Musculoskeletal disorders (MSD) are among the main causes of pain and disability in adults. Tendon disorders are an important part of MSD. Among them, the rupture of the Achilles tendon is the most common, with a prevalence of about 18 to 100000. The disorder mostly affects men between 30 and 50 years. Up today, the mechanical and elastic properties of the Achilles tendon are still unknown, and that both in healthy subjects in pathology. The viscoelastic properties or dynamic mechanical properties are directly related to the tendon of the health status and its elongation capacity. Additional tests that we have to explore the Achilles tendon are ultrasound and MRI. They bring mainly morphological information but can not demonstrate the mechanical properties of the tendon.

For this purpose, the laboratory UMR Inserm U930 - CNRS ERL 3106 in Tours has developed a non-invasive ultrasonic device, named Achillus, which, via an ultrasonic probe, allowing to access the viscoelastic properties of the tendon during the contraction of the sural triceps. It is therefore important in the exploratory work we propose to have a proven method of calibration of forces applied to the tendon, which is why an ergometer laboratory biomechanics and bioengineering at UT Compiègne is associated with our experiments.

No human study has yet been conducted to evaluate this method in medically relevant situations such as hyper solicitation and incorporated rupture.

This is what we want to do in this first protocol: in vivo observation of the normal values and variations, looking for changes related to hyper solicitation and finally trying to highlight a tendon fragility parameter for patients who have experienced of a Achilles tendon rupture.

Eligibility criteria: Inclusion Criteria:

Groupe I

* Male
* Between 18 and 60 years-old
* Informed consent form signed
* Affiliated to medical insurance

Groupe II

* Male
* Between 18 and 60 years-old
* Informed consent form signed
* Affiliated to medical insurance
* pathology of lower limb, from surgical treatment, and requiring an immobilization longer than one month and lower than two months, with discharge without support. Inclusion in the study will be done during within 48h from the onset of the immobilization

Groupe III

* Male
* Between 18 and 60 years-old
* Informed consent form signed
* Affiliated to medical insurance
* Antecedent of unilateral Achilles tendon breakage during the last 10 years (without breakage during the year previous the inclusion).

Exclusion Criteria:

Groupe I

* Know pathologies of collagen
* Antecedent of surgery on studied lower limb, located under the knee
* Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months
* Muscular or neurologic pathology with impact on lower limbs
* Acute pathology able to compromise quality of the research (infectious, organic failure, pain ...)
* Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones ...)
* Adult under guardianship
* Person under an exclusion period of other biomedical research

Groupe II

* Know pathologies of collagen
* Antecedent of surgery on studied lower limb, located under the knee
* Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months
* Muscular or neurologic pathology with impact on healthy lower limb
* Acute pathology able to compromise quality of the research (infectious, organic failure, pain ...)
* Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones ...)
* Adult under guardianship
* Person under an exclusion period of other biomedical research

Groupe III

* Know pathologies of collagen
* Antecedent of surgery on studied lower limb, located under the knee
* Pathology requiring a relief, a sport stoppage prescribed by a physician for a lower limb pathology during the last 12 months (including a controlateral Achilles tendon breakage)
* Muscular or neurologic pathology with impact on lower limbs
* Acute pathology able to compromise quality of the research (infectious, organic failure, pain ...)
* Treatments able to affect the results of the research (myorelaxant, molecule changing the muscular tonus, quinolones ...)
* Adult under guardianship
* Person under an exclusion period of other biomedical research

Primary outcomes:
measure: Measures of received signals of the ultrasound sensors and measures of applied strength on the pedal during
timeFrame: up to 3 months
Secondary outcomes:
measure: score IPAQ questionnaire
timeFrame: up to 3 months
measure: Examination data
timeFrame: baseline
measure: time of hyper stress
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Tours
country: France
facility: Univesity Hospital of Tours
Study officials:
References: