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Completed

NCT Number: NCT02567058

Biomechanical and Ultrasonic Assessment of the Achilles Tendon in Vivo (MEDUSAA)

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Univesity Hospital of Tours

Tours, 37044, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound Exam

Device

Ultrasound exam with :

  • 2 successions of 3 measures repeated for 2 visits (day 0 and day 21) for group I
  • 1 succession of 3 measures repeated for 4 visits (day 0, day 14, day 45, day 90)for group II
  • 1 succession of 3 measures for group III

Other names: Achillus, Ergometer

IPAQ questionnaire

Behavioral

IPAQ questionnaire

Primary outcomes

  1. Measures of received signals of the ultrasound sensors and measures of applied strength on the pedal during

    Time frame: up to 3 months

    This is the measure of received signals of the ultrasound sensors and measures of applied strength on the pedal during plantar flexion efforts.

    Untreated data will be treated to extract this following parameters :

    • Control of rotational strengths couple applied by the participant
    • Simultaneous speed measure of lateral wave along the Achilles tendon The set oh these data will be got with an initial isometric effort at 20, 50, 80% of the de maximal voluntary muscle contraction previously measured

Secondary outcomes

  1. score IPAQ questionnaire

    Time frame: up to 3 months

    Clinical parameter :score questionnaire of average physical activity of persons, determined by IPAQ questionnaire

  2. Examination data

    Time frame: baseline

    Examination data : age, size, weight, laterality, smoking history

  3. time of hyper stress

    Time frame: up to 3 months

    time of hyper stress

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: MEDUSAA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2015
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.