Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Not Applicable

Completed

• Conditions: Shoulder Injuries; Knee Injuries; Ankle Injuries

• Registration Number: NCT04936412
• Lead Sponsor: Jia-kuo yu

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-27
• Study Start: 2018-06-30
• Primary Completion: 2019-03-31
• Study Completion: 2019-04-30
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Study First Posted: 2021-06-23
• Last Update Posted: 2021-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
appearance score	six weeks after injury	Patient's preference for appearance
comfort score	two weeks after injury	Patient comfort score
Convenience score	six weeks after injury	Convenience of adjustment during rehabilitation
Satisfaction score	six weeks after injury	Overall satisfaction of patients

Trial Locations

Locations (1)

Institute of Sports Medicine, Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China