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Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04936412
Enrollment
40
Registered
2021-06-23
Start date
2018-06-30
Completion date
2019-04-30
Last updated
2021-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Injuries, Knee Injuries, Shoulder Injuries

Keywords

Personalized, brace, shoulder, knee, ankle

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.

Interventions

DEVICERehabilitation brace

Rehabilitation brace

Sponsors

Jia-kuo yu
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
appearance scoresix weeks after injuryPatient's preference for appearance
comfort scoretwo weeks after injuryPatient comfort score
Convenience scoresix weeks after injuryConvenience of adjustment during rehabilitation
Satisfaction scoresix weeks after injuryOverall satisfaction of patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026