Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Knee Injuries Clinical Trial

Official title:

Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936412
• Other study ID #: Personalized brace
• Status: Completed
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Knee Injuries
• Shoulder Injuries
• Wounds and Injuries

Intervention

Device:
• Rehabilitation brace
Rehabilitation brace

Locations

Country	Name	City	State
China	Institute of Sports Medicine, Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jia-kuo yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	appearance score	Patient's preference for appearance	six weeks after injury
Primary	comfort score	Patient comfort score	two weeks after injury
Primary	Convenience score	Convenience of adjustment during rehabilitation	six weeks after injury
Primary	Satisfaction score	Overall satisfaction of patients	six weeks after injury