ORLINT & ORLEXT: Orthosis for Knee (ORLINT&ORLEXT)

University of Salamanca

Status: Begins enrollment this month

Conditions: Knee Brace; Knee

Treatments: Device: Conventional orthosis device; Device: Orlint-Orlext orthosis device

Study type: Interventional

Funder types: Other

Identifiers

NCT07333911

University of Salamanca

ORLINT&ORLEXT2026

Details and patient eligibility

About

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.

Enrollment: 4 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Orlint-Orlext orthosis group

Experimental group

Description:

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.

Treatment:

Device: Orlint-Orlext orthosis device

Conventional orthesis group

Active Comparator group

Description:

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

Treatment:

Device: Conventional orthosis device