Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Conditions
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Knee Injuries, Ankle Injuries, Shoulder Injuries

Intervention / Treatment
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* Device: Rehabilitation brace


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized brace group<br>Personalized brace for patients | Device: Rehabilitation brace<br>* Rehabilitation brace<br>* Other names: Individualized rehabilitation support;|
| Active Comparator: Conventional brace group<br>Conventional brace for patients | Device: Rehabilitation brace<br>* Rehabilitation brace<br>* Other names: Individualized rehabilitation support;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appearance score | Patient's preference for appearance | six weeks after injury | 
| comfort score | Patient comfort score | two weeks after injury | 
| Convenience score | Convenience of adjustment during rehabilitation | six weeks after injury | 
| Satisfaction score | Overall satisfaction of patients | six weeks after injury | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Personalized, brace, shoulder, knee, ankle