Skip to main content
OpenTrials
Completed

NCT Number: NCT04936412

Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

This study is based on human anatomical data and uses computer-aided engineering (CAE) software such as biomedical image processing software, reverse engineering software, CAD software, and finite element analysis software to create a three-dimensional bracing model. With the help of 3D printing technology, we have developed personalized brace, completed the personalized rapid design and optimization of the three series of support equipment products such as the posterior cruciate ligament brace, ankle ankle brace, and shoulder brace.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shoulder Injuries Ankle Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

The traditional brace mainly includes small splints or gypsums. The manufacturing process is rough, and the flexibility is poor. In recent years, with the development of orthopedic surgery, rehabilitation concept, modern polymer materials, and biomechanics, great progress has been made in R&D, production, and assembly of orthoses. In developed countries, orthoses is not only widely used after orthopedic surgery and the department of rehabilitation, but it has become the main auxiliary device for sports trauma surgery, immobilization, treatment, and rehabilitation training. Leading bracing company such as DJO has developed multi-brand correction devices such as Aircast®, Chattanooga, CMF, COMPEX®, DonJoy®, Empi® and ProCare®. However, these braces are not designed and manufactured based on patients. Individually designed products for anatomical structures still have many problems in clinical applications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients accepting arthroscopic surgery of the shoulder, posterior cruciate ligament reconstruction surgery, Achilles tendon rupture repair surgery.

Exclusion criteria

  • Severe peripheral ligament injury of should, knee and ankle.

Treatment and study plan

Rehabilitation brace

Device

Rehabilitation brace

Other names: Individualized rehabilitation support

Primary outcomes

  1. appearance score

    Time frame: six weeks after injury

    Patient's preference for appearance

  2. comfort score

    Time frame: two weeks after injury

    Patient comfort score

  3. Convenience score

    Time frame: six weeks after injury

    Convenience of adjustment during rehabilitation

  4. Satisfaction score

    Time frame: six weeks after injury

    Overall satisfaction of patients

Sponsors and collaborators

Lead sponsor

Jia-kuo yu

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2021
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.