Distal Tubercle Fractures of the ScaphoidNCT02366234
Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid
An observational study of Distal Tubercle Fractures of the Scaphoid, run by Massachusetts General Hospital.
Trial summary
AIM: The aim of this study is to assess whether patients with an acute distal tubercle fracture of the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms and disability 6 months after injury as the average for the normal population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Tubercle Fractures of the Scaphoid
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with distal tubercle fracture of the scaphoid
Who may be able to join
- Age > 18 years
- Fracture of the distal tubercle of the scaphoid on radiographs
- Interval between injury and diagnosis of less than 2 months
- English or Spanish fluency and literacy
Who cannot join
- Pregnant women
- Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness)
- Patients with other fractures or injuries
About this study
AIM:
The aim of this study is to assess whether patients with an acute distal tubercle fracture of the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms and disability 6 months after injury as the average for the normal population.
NULL HYPOTHESIS:
Patients with an acute distal tubercle fracture of the scaphoid have Quick DASH (Disabilities of the Arm Shoulder and Hand) scores at or above the population norm (a score of 13 in Norway and 10.9 in the United States) 6 months after injury when treated symptomatically with a removable brace.
Read the detailed description
Fractures of the distal scaphoid tubercle are uncommon and seem relatively benign. Not a lot is known in literature about this specific type of avulsion fracture and the treatment. Some surgeons recommend a cast for 4 to 6 weeks while others treat their patients with a removable brace. The only non-union reported in literature is Jonssen who published a case in 1990 about a non-union of a tubercle fracture in a patient with repeated trauma. Kraus et al studied 81 cases of acute scaphoid fractures and found 4 cases of tubercle avulsion fractures in this group. We suspect some patients will not seek care for this condition as it hurts for a bit and then causes no problems.
Response variables:
- Quick DASH measured 6 months after injury
- 11-point ordinal measure of overall pain intensity 6 months after trauma
Explanatory variables:
- Socio-demographics
- Age, sex, ethnicity, race, marital status, education, work status
- Questionnaires
- Quick DASH after trauma (< 2 weeks)
- 11-point ordinal measure of overall pain intensity 6 months after trauma
- 11-point ordinal measure of satisfaction with treatment 6 months after trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fracture of Distal Tubercle of Scaphoid | Questionnaires * Quick DASH after trauma (< 2 weeks) * 11-point ordinal measure of overall pain intensity 6 months after trauma * 11-point ordinal measure of satisfaction with treatment 6 months after trauma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability with use of QuickDASH
Measured: 2 weeks
Secondary outcomes (2)
Overall Pain Intensity
Pain Intensity measured with an 11-point ordinal measure of overall pain intensity 6 months after trauma
Measured: 6 months
Satisfaction with Treatment
Satisfaction measured with an 11-point ordinal measure of satisfaction with treatment 6 months after trauma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: The investigator left the institution so the study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Tubercle Fractures of the ScaphoidStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Haaglanden Medical Centre, Skane University Hospital, Ghaem Hospital
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366234
- Sponsor's protocol ID
- 2014P002670
- Status last verified
- Dec 2016
- First submitted
- 6 Feb 2015
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomatic Treatment of Distal Tubercle Fractures of the Scaphoid
- ClinicalTrials.gov ID
- NCT02366234
- Acronym / sponsor ID
- 2014P002670
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The investigator left the institution so the study was terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Haaglanden Medical Centre, Skane University Hospital, Ghaem Hospital
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Feb 2015 (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.
AIM:
The aim of this study is to assess whether patients with an acute distal tubercle fracture of the scaphoid treated with a removable brace for 4 to 6 weeks have the same level of symptoms and disability 6 months after injury as the average for the normal population.
NULL HYPOTHESIS:
Patients with an acute distal tubercle fracture of the scaphoid have Quick DASH (Disabilities of the Arm Shoulder and Hand) scores at or above the population norm (a score of 13 in Norway and 10.9 in the United States) 6 months after injury when treated symptomatically with a removable brace.
Detailed description
Fractures of the distal scaphoid tubercle are uncommon and seem relatively benign. Not a lot is known in literature about this specific type of avulsion fracture and the treatment. Some surgeons recommend a cast for 4 to 6 weeks while others treat their patients with a removable brace. The only non-union reported in literature is Jonssen who published a case in 1990 about a non-union of a tubercle fracture in a patient with repeated trauma. Kraus et al studied 81 cases of acute scaphoid fractures and found 4 cases of tubercle avulsion fractures in this group. We suspect some patients will not seek care for this condition as it hurts for a bit and then causes no problems.
Response variables:
- Quick DASH measured 6 months after injury
- 11-point ordinal measure of overall pain intensity 6 months after trauma
Explanatory variables:
- Socio-demographics
- Age, sex, ethnicity, race, marital status, education, work status
- Questionnaires
- Quick DASH after trauma (< 2 weeks)
- 11-point ordinal measure of overall pain intensity 6 months after trauma
- 11-point ordinal measure of satisfaction with treatment 6 months after trauma
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fracture of Distal Tubercle of Scaphoid | – | –Questionnaires * Quick DASH after trauma (< 2 weeks) * 11-point ordinal measure of overall pain intensity 6 months after trauma * 11-point ordinal measure of satisfaction with treatment 6 months after trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with distal tubercle fracture of the scaphoid
Key inclusion criteria (4 listed)
- Age > 18 years
- Fracture of the distal tubercle of the scaphoid on radiographs
- Interval between injury and diagnosis of less than 2 months
- English or Spanish fluency and literacy
Key exclusion criteria (3 listed)
- Pregnant women
- Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness)
- Patients with other fractures or injuries
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
Disability with use of QuickDASH
Time frame: 2 weeks
2 secondary outcomes
Overall Pain Intensity
Time frame: 6 months
Satisfaction with Treatment
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
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.
David Ring, MD PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Distal Tubercle Fractures of the Scaphoid, run by Massachusetts General Hospital.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Disability with use of QuickDASH (time frame: 2 weeks). 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 22 Dec 2016.