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Starting soon Not applicable

ORLINT & ORLEXT: Orthosis for Knee

NCT07333911 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-07-01
Last updated
2026-04-28

Condition(s) studied

Knee BraceKnee

Investigational drug(s) / intervention(s)

Orlint-Orlext orthosis deviceConventional orthosis device

Orlint-Orlext orthosis device: 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 device: Participants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patients with chronic knee injuries * patients who have already been prescribed an orthosis * patients older than 18 years old Exclusion Criteria: * inability to stand actively and stably * inability to walk unaided

Primary outcome measure(s)

  • Device feasibility — 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

Trial sites (1)

FacilityCityRegionStatus
University of Salamanca Salamanca Salamanca
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07333911 on ClinicalTrials.gov ↗ ← All trials in Spain