Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Jia-kuo yu

Status: Completed

Conditions: Knee Injuries; Shoulder Injuries; Ankle Injuries

Treatments: Device: Rehabilitation brace

Study type: Interventional

Funder types: Other

Identifiers

NCT04936412

Personalized brace

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Personalized brace group

Experimental group

Description:

Personalized brace for patients

Treatment:

Device: Rehabilitation brace

Conventional brace group

Active Comparator group

Description:

Conventional brace for patients

Treatment:

Device: Rehabilitation brace