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Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Primary Purpose

Shoulder Injuries, Knee Injuries, Ankle Injuries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rehabilitation brace
Sponsored by
Jia-kuo yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries focused on measuring Personalized, brace, shoulder, knee, ankle

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Sports Medicine, Peking University Third Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized brace group

Conventional brace group

Arm Description

Personalized brace for patients

Conventional brace for patients

Outcomes

Primary Outcome Measures

appearance score
Patient's preference for appearance
comfort score
Patient comfort score
Convenience score
Convenience of adjustment during rehabilitation
Satisfaction score
Overall satisfaction of patients

Secondary Outcome Measures

Full Information

First Posted
May 27, 2018
Last Updated
June 16, 2021
Sponsor
Jia-kuo yu
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1. Study Identification

Unique Protocol Identification Number
NCT04936412
Brief Title
Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace
Official Title
Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jia-kuo yu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries, Knee Injuries, Ankle Injuries
Keywords
Personalized, brace, shoulder, knee, ankle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized brace group
Arm Type
Experimental
Arm Description
Personalized brace for patients
Arm Title
Conventional brace group
Arm Type
Active Comparator
Arm Description
Conventional brace for patients
Intervention Type
Device
Intervention Name(s)
Rehabilitation brace
Other Intervention Name(s)
Individualized rehabilitation support
Intervention Description
Rehabilitation brace
Primary Outcome Measure Information:
Title
appearance score
Description
Patient's preference for appearance
Time Frame
six weeks after injury
Title
comfort score
Description
Patient comfort score
Time Frame
two weeks after injury
Title
Convenience score
Description
Convenience of adjustment during rehabilitation
Time Frame
six weeks after injury
Title
Satisfaction score
Description
Overall satisfaction of patients
Time Frame
six weeks after injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Lin
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Sports Medicine, Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

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