Knee BraceORLINT&ORLEXTNCT07333911
ORLINT & ORLEXT: Orthosis for Knee
A study testing Orlint-Orlext orthosis device and Conventional orthosis device in people with Knee Brace and Knee, run by University of Salamanca at 1 site in Spain.
Trial summary
The goal of this experimental study is to test the feasibility and validity of a new orthosis in patients with lateral ligament knee lesions of both sexes and older than 18 years old. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Brace, Knee
- What is being tested?
- Orlint-Orlext orthosis device and Conventional orthosis device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with chronic knee injuries
- patients who have already been prescribed an orthosis
- patients older than 18 years old
Who cannot join
- inability to stand actively and stably
- inability to walk unaided
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ORLINT & ORLEXT: New Orthosis for the Lateral Knee Ligaments
The goal of this experimental study is to test the feasibility and validity of a new orthosis in patients with lateral ligament knee lesions of both sexes and older than 18 years old. The main question it aims to answer is:
Is the new orthosis a support for knee stability?? Does the new orthosis improve knee function and patients' quality of life??
The control group will be the subjects themselves when wearing their conventional knee orthosis or without it.
Participants must wear the new knee orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the knee joint and muscles.
- Conditions
- Knee Brace, Knee
- Being tested
- Orlint-Orlext orthosis device, Conventional orthosis device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orlint-Orlext orthosis deviceDevice
Participants must wear the new knee orthosis during assessments and in their daily lives for at least one month, which is the duration of the study.
Conventional orthosis deviceDevice
Participants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one
| Study group | Role | What they receive |
|---|---|---|
| Orlint-Orlext orthosis group | Experimental | Participants must wear the new knee orthosis during assessments and in their daily lives for at least one month, which is the duration of the study. Receives: Device: Orlint-Orlext orthosis device |
| Conventional orthesis group | Active comparator | Participants must wear the conventional knee orthosis (a without orthosis) during assessments and in their daily lives, before wear the new one. Receives: Device: Conventional orthosis device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device feasibility
Device feasibility will be assessed through participants' awareness of the device, as an indicator of its accessibility, visibility, and potential for effective implementation within the target population. A self-diary will be requested
Measured: Baseline and up to 4 weeks
Secondary outcomes (3)
Knee function with virtual reality
Knee function will be assessed using a virtual reality programme that requires movement of the lower limb to assess knee stability, with and without orthosis. The assessment will be using a Borg scale (range of effort that the individual perceives when exercising). From 0 points (minimum effort) to 10 points (maximum effort).
Measured: Baseline and up to 4 weeks
Range of motion with a Gyko device
The range of motion of the knee joint will be measured using the Gyko device with and without the new orthosis. It will be measured in degrees (0-120º)
Measured: Baseline and up to 4 weeks
Footprint with a pressure platform
The distribution of static and dynamic load will be assessed with and without orthosis, using a pressure platform, as well as static balance with eyes open and closed and dynamic balance. The meausure will be the percentaje of support from the sole of the foot.
Measured: Baseline and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee BraceStudies 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Llamas-Ramos, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333911
- Sponsor's protocol ID
- ORLINT&ORLEXT2026
- Other IDs
- University of Salamanca
- Acronym
- ORLINT&ORLEXT
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 28 Apr 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORLINT & ORLEXT: New Orthosis for the Lateral Knee Ligaments
- ClinicalTrials.gov ID
- NCT07333911
- Acronym / sponsor ID
- ORLINT&ORLEXT / ORLINT&ORLEXT2026
- Conditions
- Knee Brace, Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 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.
The goal of this experimental study is to test the feasibility and validity of a new orthosis in patients with lateral ligament knee lesions of both sexes and older than 18 years old. The main question it aims to answer is:
Is the new orthosis a support for knee stability?? Does the new orthosis improve knee function and patients' quality of life??
The control group will be the subjects themselves when wearing their conventional knee orthosis or without it.
Participants must wear the new knee orthosis for at least one month to assess the effectiveness of the orthosis and evaluate any changes that have occurred in the knee joint and muscles.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orlint-Orlext orthosis group | Experimental | Device: Orlint-Orlext orthosis deviceParticipants must wear the new knee orthosis during assessments and in their daily lives for at least one month, which is the duration of the study. |
| Conventional orthesis group | Active comparator | Device: Conventional orthosis deviceParticipants must wear the conventional knee orthosis (a without orthosis) during assessments and in their daily lives, before wear the new one. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with chronic knee injuries
- patients who have already been prescribed an orthosis
- patients older than 18 years old
Key exclusion criteria (2 listed)
- inability to stand actively and stably
- inability to walk unaided
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 |
|---|---|---|
| Orlint-Orlext orthosis deviceParticipants must wear the new knee orthosis during assessments and in their daily lives for at least one month, which is the duration of the study. | Device | Orlint-Orlext orthosis group |
| Conventional orthosis deviceParticipants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one | Device | Conventional orthesis group |
Primary outcome
Device feasibility
Time frame: Baseline and up to 4 weeks
Device feasibility will be assessed through participants' awareness of the device, as an indicator of its accessibility, visibility, and potential for effective implementation within the target population. A self-diary will be requested
3 secondary outcomes
Knee function with virtual reality
Time frame: Baseline and up to 4 weeks
Range of motion with a Gyko device
Time frame: Baseline and up to 4 weeks
Footprint with a pressure platform
Time frame: Baseline and up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orlint-Orlext orthosis device and Conventional orthosis device in people with Knee Brace and Knee, run by University of Salamanca at 1 site in Spain.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Apr 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rocío Llamas-Ramos Dr. (+3465785488, rociollamas@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device feasibility (time frame: Baseline and up to 4 weeks). 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 28 Apr 2026.