Soft Tissue Characterization of the Knee RegionKneeDentNCT07640178
Knee Indentation for Soft Tissues Mechanical Characterization and Modeling
A study testing Knee indentation in people with Soft Tissue Characterization of the Knee Region, run by Centre de recherche Inria de l'Université de Rennes at 1 site in France.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Characterization of the Knee Region
- What is being tested?
- Knee indentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2026to 24 Apr 2026
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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…).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indentation for the Mechanical Characterization of Soft Tissues in Contact With a Knee Orthosis: Towards Simulation of the Leg-Orthosis Interface.
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.
- Being tested
- Knee indentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee indentationOther
we push the soft tissue in the indentation zone with an instrumented elastographic probe, allowing to assess force vs tissue thickness.
| Study group | Role | What they receive |
|---|---|---|
| Knee indentation | Experimental | under different level of thigh and shank muscles contraction, we indent specific zones of the knee region to assess its stiffness and define a mechanical model of response for knee orthosis design Receives: Other: Knee indentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
force-displacement curves
Using the force below and displacement below, this a construction of the relative displacement with regard to the applied force
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Indentation force (N)
Force being applied by the indenter on the zone to be indented
Measured: through study completion, an average of 1 year
Displacement (mm)
using motion capture, this is the assessment of the relative displacement of the probe with regard to the resting position during an indentation
Measured: through study completion, an average of 1 year
Height (m)
Height of the subject, measured with a standard ruler
Measured: through study completion, an average of 1 year
Weight (kg)
measured with a standard scale
Measured: through study completion, an average of 1 year
Muscle activity (mV)
from the main flexors and extensors of the thigh, using EMGs
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start19 Mar 2026
- Primary completion24 Apr 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Characterization of the Knee RegionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de recherche Inria de l'Université de Rennes
- Sponsor type
- University, hospital or other
- Collaborators
- Lyon 1 University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640178
- Sponsor's protocol ID
- InriaRennes
- Other IDs
- Étude N°26.00181.001002
- Acronym
- KneeDent
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indentation for the Mechanical Characterization of Soft Tissues in Contact With a Knee Orthosis: Towards Simulation of the Leg-Orthosis Interface.
- ClinicalTrials.gov ID
- NCT07640178
- Acronym / sponsor ID
- KneeDent / InriaRennes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre de recherche Inria de l'Université de RennesUniversity, hospital or other
- Collaborators
- Lyon 1 University
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 10 Jun 2026 (actual)
- 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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee indentation | Experimental | Other: Knee indentationunder different level of thigh and shank muscles contraction, we indent specific zones of the knee region to assess its stiffness and define a mechanical model of response for knee orthosis design |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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…).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Knee indentationwe push the soft tissue in the indentation zone with an instrumented elastographic probe, allowing to assess force vs tissue thickness. | Other | Knee indentation |
Primary outcome
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
5 secondary outcomes
Indentation force (N)
Time frame: through study completion, an average of 1 year
Displacement (mm)
Time frame: through study completion, an average of 1 year
Height (m)
Time frame: through study completion, an average of 1 year
Weight (kg)
Time frame: through study completion, an average of 1 year
Muscle activity (mV)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee indentation in people with Soft Tissue Characterization of the Knee Region, run by Centre de recherche Inria de l'Université de Rennes 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 0 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: finished, as of the sponsor's last update on 10 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
force-displacement curves (time frame: through study completion, an average of 1 year). 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 10 Jun 2026.