Fracture of Distal End of RadiusNCT01752452
Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation
An observational study of Fracture of Distal End of Radius and Fracture of Ulnar Styloid, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Fracture of Distal End of Radius, Fracture of Ulnar Styloid
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Oct 2012
- How long will I take part?
- 2 Years
- 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: unstable distal radial fracture patients: (1) the initial dorsal angulation >20°, (2) with dorsal or volar comminution of the metaphysis, (3) shortening of radius >5 mm, and (4) with an associated ulnar fracture.
Who may be able to join
- unstable distal radial fracture
- fixed with external fixator
Who cannot join
- multiple fracture
- open fracture
- nerve injury
- vascular injury
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.
What is being measured
The primary outcome is the main question the study is designed to answer.
wrist motion range
extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination
Measured: 3 months, 6 months, and 1 year
ulnar sided pain
presence of ulnar-sided wrist pain during daily activities was recorded
Measured: 3 months, 6 months, and 1 year
Secondary outcomes (1)
radiographic analysis
Standard anterior-posterior and lateral radiographs were obtained at each time point to evaluate fracture healing and the alignment of the distal part of the radius. Radial inclination, volar tilt, and radial height were measured
Measured: 6 weeks, 3 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJan 2009
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture of Distal End of RadiusStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-xin Chen, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Yi-xin Chen, M.D., Principal investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752452
- Sponsor's protocol ID
- BE20116003
- Status last verified
- Dec 2012
- First submitted
- 11 Dec 2012
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ulnar Styloid Fracture on the Outcome of Distal Radial Fractures Treated With External Fixation
- ClinicalTrials.gov ID
- NCT01752452
- Acronym / sponsor ID
- BE20116003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 19 Dec 2012 (estimated)
- 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.
Untreated ulnar styloid fracture may affect the outcomes of distal radial fracture patient treated with external fixation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- unstable distal radial fracture patients: (1) the initial dorsal angulation >20°, (2) with dorsal or volar comminution of the metaphysis, (3) shortening of radius >5 mm, and (4) with an associated ulnar fracture.
Key inclusion criteria (2 listed)
- unstable distal radial fracture
- fixed with external fixator
Key exclusion criteria (4 listed)
- multiple fracture
- open fracture
- nerve injury
- vascular injury
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
wrist motion range
Time frame: 3 months, 6 months, and 1 year
extension, flexion, radial deviation, ulnar deviation, forearm pronation and forearm supination
ulnar sided pain
Time frame: 3 months, 6 months, and 1 year
presence of ulnar-sided wrist pain during daily activities was recorded
1 secondary outcome
radiographic analysis
Time frame: 6 weeks, 3 months, and 1 year
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 19 Dec 2012.
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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.
Yi-xin Chen, M.D. principal investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 Fracture of Distal End of Radius and Fracture of Ulnar Styloid, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 2 inclusion and 4 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 19 Dec 2012. 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?
wrist motion range (time frame: 3 months, 6 months, and 1 year). The study lists 2 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 19 Dec 2012.