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OpenTrials
Completed

NCT Number: NCT07640178

Knee Indentation for Soft Tissues Mechanical Characterization and Modeling

Knee osteoarthritis is a common cause of disability, affecting more than 650 million people aged 40 and over worldwide in 2020. To relieve pain and improve mobility, some patients use knee orthoses . However, the effectiveness of these devices is not universally agreed upon, and users report widely varying levels of satisfaction.

This study aims to understand how the body responds to these orthoses from a biomechanical perspective, and in particular to quantify the interactions with soft tissues (skin, adipose tissue and muscles). To better understand this interaction, the authors propose to characterize soft tissue behavior on an individual basis using an indentation technique. In practice, this involves pressing on the soft tissues with an ultrasound probe to measure their stiffness at the interface between the leg and the orthosis.

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Key information

Conditions

Soft Tissue Characterization of the Knee Region

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ens Rennes

Bruz, Ille-et-Vilaine, 35170, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Participant whose skin is intact on at least one of the two legs, in the tested area.

Participant able to understand simple instructions, conditioning guidelines, and to provide informed consent.

Adult over the age of 50, not under guardianship. Participant having signed the study participation consent form.

Non-inclusion Criteria

Persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 (minors, protected adults, etc.) Skin lesions, inflammation, or acute local pain on the tested leg. Neuromuscular pathology preventing controlled muscle contraction. Joint pain preventing the performance of everyday activities (e.g., walking, rising from a chair, climbing stairs…).

Treatment and study plan

Knee indentation

Other

we push the soft tissue in the indentation zone with an instrumented elastographic probe, allowing to assess force vs tissue thickness.

Primary outcomes

  1. force-displacement curves

    Time frame: through study completion, an average of 1 year

    Using the force below and displacement below, this a construction of the relative displacement with regard to the applied force

Secondary outcomes

  1. Indentation force (N)

    Time frame: through study completion, an average of 1 year

    Force being applied by the indenter on the zone to be indented

  2. Displacement (mm)

    Time frame: through study completion, an average of 1 year

    using motion capture, this is the assessment of the relative displacement of the probe with regard to the resting position during an indentation

  3. Height (m)

    Time frame: through study completion, an average of 1 year

    Height of the subject, measured with a standard ruler

  4. Weight (kg)

    Time frame: through study completion, an average of 1 year

    measured with a standard scale

  5. Muscle activity (mV)

    Time frame: through study completion, an average of 1 year

    from the main flexors and extensors of the thigh, using EMGs

Sponsors and collaborators

Lead sponsor

Centre de recherche Inria de l'Université de Rennes

Other

Collaborators

  • Lyon 1 University

Registry information

Official study title

Indentation for the Mechanical Characterization of Soft Tissues in Contact With a Knee Orthosis: Towards Simulation of the Leg-Orthosis Interface.

Acronym: KneeDent

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

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.