Distal Radius FractureNCT03556514
Follow-up for Locking Plate Fixaion of Distal Radius Fracture
An observational study of Distal Radius Fracture, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The current status of the disease under study. Including natural history, disease prognosis. Distal radial fractures (DRF, distal radius fractures) are the most common fractures, allowing the user to lock the steel plate to accelerate the recovery of the wrist, but related injuries such as the triangular… Read more about this study
- Who is it for?
- Ages 24 years and older
- Conditions the study is for
- Distal Radius Fracture
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 May 2017to 9 May 2019
- Phase
- Observational
- 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 24 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute distal humerus fracture after interlocking plate fixation
Who may be able to join
- Outpatient following for at least one year
Who cannot join
- (1) Injury or arthritis before; (2) Open fractures, or more wounds require surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei
Jung-Pan Wang, M.D.,Ph.D.
About this study
The current status of the disease under study. Including natural history, disease prognosis.
Distal radial fractures (DRF, distal radius fractures) are the most common fractures, allowing the user to lock the steel plate to accelerate the recovery of the wrist, but related injuries such as the triangular fibrocartilage cartilage complex (TFCC) tear or distal radius ulna joint (DRUJ) ligament tear with DRUJ instability requires time fixed or further repair surgery. If these issues are ignored, there will be weakness in the future. The ulnar shortening commonly used by hand surgeons is to improve the damage of TFCC or DRUJ instability. In the case of distal radial fracture combined with DRUJ instability, it is not clear that the distal radial fracture combined with DRUJ instability patients has long-term prognosis.
- Conditions
- Distal Radius Fracture
- Keywords
- Locking Plate Fixaion
- Medical subject headings
- Wrist Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
4-Item Pain intensity Measure
Each item is scored 0-10(0=no pain;10=pain as bad as can be)
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start10 May 2017
- Primary completion9 May 2019 (estimated)
- Study completion9 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jung-Pan Wang, M.D.,Ph.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556514
- Sponsor's protocol ID
- 2017-05-009AC
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2018
- Last updated
- 14 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up for Locking Plate Fixaion of Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT03556514
- Acronym / sponsor ID
- 2017-05-009AC
- Conditions
- Distal Radius Fracture
- Keywords
- Locking Plate Fixaion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 10 May 2017 (actual)
- Primary completion
- 9 May 2019 (estimated)
- Study completion
- 9 May 2019 (estimated)
- First posted
- 14 Jun 2018 (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.
The current status of the disease under study. Including natural history, disease prognosis.
Distal radial fractures (DRF, distal radius fractures) are the most common fractures, allowing the user to lock the steel plate to accelerate the recovery of the wrist, but related injuries such as the triangular fibrocartilage cartilage complex (TFCC) tear or distal radius ulna joint (DRUJ) ligament tear with DRUJ instability requires time fixed or further repair surgery. If these issues are ignored, there will be weakness in the future. The ulnar shortening commonly used by hand surgeons is to improve the damage of TFCC or DRUJ instability. In the case of distal radial fracture combined with DRUJ instability, it is not clear that the distal radial fracture combined with DRUJ instability patients has long-term prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute distal humerus fracture after interlocking plate fixation
Key inclusion criteria (1 listed)
- Outpatient following for at least one year
Key exclusion criteria (1 listed)
- (1) Injury or arthritis before; (2) Open fractures, or more wounds require surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
4-Item Pain intensity Measure
Time frame: 5 seconds
Each item is scored 0-10(0=no pain;10=pain as bad as can be)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
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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.
Jung-Pan Wang, M.D.,Ph.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Radius Fracture, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 14 Jun 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Pan Wang, M.D.,Ph.D. (02-28757557 ext. 1125, jpwang801@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-Item Pain intensity Measure (time frame: 5 seconds). 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 14 Jun 2018.