ORLINT & ORLEXT: Orthosis for Knee

NCT ID: NCT07333911

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Brace Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Orlint-Orlext orthosis group

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.

Group Type EXPERIMENTAL

Orlint-Orlext orthosis device

Intervention Type 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 orthesis group

Participants must wear the conventional knee orthosis (a without orthosis) during assessments and in their daily lives, before wear the new one.

Group Type ACTIVE_COMPARATOR

Conventional orthosis device

Intervention Type DEVICE

Participants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one

Interventions

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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.

Intervention Type DEVICE

Conventional orthosis device

Participants must wear the conventional knee orthosis and without orthosis, during assessments and before wearing the new one

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Rocío Llamas-Ramos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Salamanca

Salamanca, Salamanca, Spain

Site Status

Countries

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Spain

Central Contacts

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Rocío Llamas-Ramos Dr.

Role: CONTACT

+3465785488

Other Identifiers

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University of Salamanca

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ORLINT&ORLEXT2026

Identifier Type: -

Identifier Source: org_study_id

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