Shoulder InjuriesNCT04936412
Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace
A study testing Rehabilitation brace in people with Shoulder Injuries and Knee Injuries, run by Jia-kuo yu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Shoulder Injuries, Knee Injuries, Ankle Injuries
- What is being tested?
- Rehabilitation brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients accepting arthroscopic surgery of the shoulder, posterior cruciate ligament reconstruction surgery, Achilles tendon rupture repair surgery.
Who cannot join
- Severe peripheral ligament injury of should, knee and ankle.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Sports Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
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.
Read the 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.
- Conditions
- Shoulder Injuries, Knee Injuries, Ankle Injuries
- Being tested
- Rehabilitation brace
- Keywords
- Personalized, brace, shoulder, knee, ankle
- Medical subject headings
- Shoulder Injuries, Knee Injuries, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation braceDevice
Also called Individualized rehabilitation support
Rehabilitation brace
| Study group | Role | What they receive |
|---|---|---|
| Personalized brace group | Experimental | Personalized brace for patients Receives: Device: Rehabilitation brace |
| Conventional brace group | Active comparator | Conventional brace for patients Receives: Device: Rehabilitation brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
appearance score
Patient's preference for appearance
Measured: six weeks after injury
comfort score
Patient comfort score
Measured: two weeks after injury
Convenience score
Convenience of adjustment during rehabilitation
Measured: six weeks after injury
Satisfaction score
Overall satisfaction of patients
Measured: six weeks after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start30 Jun 2018
- Primary completion31 Mar 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jia-kuo yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jia-kuo yu, Peking University Third Hospital
- Investigators
- Lin Lin, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936412
- Sponsor's protocol ID
- Personalized brace
- Status last verified
- Jun 2021
- First submitted
- 27 May 2018
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Study of Personalized Shoulder, Knee and Ankle Brace
- ClinicalTrials.gov ID
- NCT04936412
- Acronym / sponsor ID
- Personalized brace
- Conditions
- Shoulder Injuries, Knee Injuries, Ankle Injuries
- Keywords
- Personalized, brace, shoulder, knee, ankle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jia-kuo yuUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized brace group | Experimental | Device: Rehabilitation bracePersonalized brace for patients |
| Conventional brace group | Active comparator | Device: Rehabilitation braceConventional brace for patients |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients accepting arthroscopic surgery of the shoulder, posterior cruciate ligament reconstruction surgery, Achilles tendon rupture repair surgery.
Key exclusion criteria (1 listed)
- Severe peripheral ligament injury of should, knee and ankle.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation braceAlso: Individualized rehabilitation supportRehabilitation brace | Device | Conventional brace group, Personalized brace group |
Primary outcome
appearance score
Time frame: six weeks after injury
Patient's preference for appearance
comfort score
Time frame: two weeks after injury
Patient comfort score
Convenience score
Time frame: six weeks after injury
Convenience of adjustment during rehabilitation
Satisfaction score
Time frame: six weeks after injury
Overall satisfaction of patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Lin study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation brace in people with Shoulder Injuries and Knee Injuries, run by Jia-kuo yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appearance score (time frame: six weeks after injury). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.