Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

June 16, 2021 updated by: Jia-kuo yu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Institute of Sports Medicine, Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized brace group
Personalized brace for patients
Device: Rehabilitation brace
Rehabilitation brace
Other Names:
  • Individualized rehabilitation support
Active Comparator: Conventional brace group
Conventional brace for patients
Device: Rehabilitation brace
Rehabilitation brace
Other Names:
  • Individualized rehabilitation support

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jia-kuo yu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2018

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

May 27, 2018

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Personalized brace

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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