ORLINT & ORLEXT: Orthosis for Knee
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Orlint-Orlext orthosis device, Conventional orthosis device.
- Who it may be relevant to
- Registry conditions: Knee Brace, Knee. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ORLINT & ORLEXT: New Orthosis for the Lateral Knee Ligaments
Overview
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.
Interventions
- 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. - Device Conventional orthosis device
Participants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one
Primary outcome measures
- Device feasibility [Time frame: Baseline and up to 4 weeks]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Device feasibility
Study locations
Spain · 1 center
- University of Salamanca — Salamanca
Identifiers
NCT: NCT07333911 · ORLINT&ORLEXT2026 · University of Salamanca