Mallet FractureNCT01583556
Optional Follow-up Visits for Common, Low-risk Arm Fractures
An observational study of Mallet Fracture and Metacarpal Fracture, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Many common arm fractures have an excellent prognosis with little more than symptomatic treatment. When studying these fractures, investigators find that a substantial number of patients do not attend follow-up appointments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mallet Fracture, Metacarpal Fracture, Metacarpal Neck Fracture
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jan 2015
- 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: All adult, English-speaking patients presenting to our outpatient clinic, that meet the inclusion criteria for this study will be invited to enroll at the time of the first visit at the outpatient clinic.
Who may be able to join
- adult (>18 years)
- English-speaking
- fracture with an excellent prognosis such as:
- nondisplaced mallet fracture
- stable, well-aligned metacarpal fracture
- all small finger metacarpal neck fractures
- non- or minimally displaced distal radius fracture treated in a removable splint
- isolated minimally displaced radial head fracture involving the radial neck or part of the articular surface
Who cannot join
- pregnant women
- no written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Many common arm fractures have an excellent prognosis with little more than symptomatic treatment. When studying these fractures, investigators find that a substantial number of patients do not attend follow-up appointments. The difficulty of maneuvering in big cities, the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are all inconveniences that some patients might prefer to avoid. Building on prior research, it is appropriate to offer patients with common minor upper extremity fractures that have an excellent prognosis optional follow-up after the first visit. The plan would be to be available by phone, email and subsequent appointment at the patient's discretion if they felt that the recovery was off course. Benefit to individual participants is unlikely. The study will benefit the society as a whole, by providing a better understanding of these common fractures. It can also affect the economics of our health system by avoiding further follow-up appointments.
Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury between patients that return for a second visit, and patients that do not.
Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after injury between patients that return for a second visit, and patients that do not.
Read the detailed description
This study will employ a prospective, non-randomized design. After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment). The alternative (Optional follow-up) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course.
Since it is up to the subject to decide whether or not he or she wants a second appointment or the brochure, it is observational rather than interventional.
Evaluation: 2-6 months after injury all patients (independent of group) will be contacted by either phone or email by a blinded research assistant and asked to provide the following: pain with NRS (scale 0-10); three satisfaction questions; disability with use of Quick DASH; and if they returned to modified and regular work.
Patients in the standard group A will return to the Hand and Upper Extremity Service for their usual practice follow-up examination 1-3 months after treatment.
- Conditions
- Mallet Fracture, Metacarpal Fracture, Metacarpal Neck Fracture, Distal Radius Fracture, Radial Head Fracture
- Keywords
- Adult, English speaking, Fractures, Excellent prognosis, Upper Extremity
- Medical subject headings
- Wrist Fractures, Radial Head and Neck Fractures, Fractures, Bone
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 |
|---|---|---|
| Standard treatment | This study will employ a prospective, non-randomized design. After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment) as our daily practice after 1-3 months. They will be contacted after 2-6 months either by phone or email and will complete again some questionnaires (Quick DASH, satisfaction, return to work). | |
| Optional follow-up group | The alternative (Optional follow-up group) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course. The questionnaires will be repeated either by phone or email in 2-6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability with use of Quick DASH
The Disabilities of Arm Shoulder and Hand (DASH) questionnaire is used frequently in hand and upper extremity research to assess disability. The Quick DASH is the short version of the DASH consisting of 11 questions.
http://www.dash.iwh.on.ca/system/files/quickdash_questionnaire_2010.pdf
Measured: Change from baseline at enrollment to follow-up at 2-6 months
Secondary outcomes (1)
Satisfaction
The investigators measure the overall current patient satisfaction with an ordinal scale from 0 to 10, 0 being completely dissatisfied, 10 being completely satisfied.
Measured: Change from baseline at enrollment to follow-up at 2-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mallet FractureStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David C. Ring, MD, Massachusetts General Hospital
- Investigators
- David Ring, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583556
- Sponsor's protocol ID
- 2012P000632
- Status last verified
- Apr 2015
- First submitted
- 27 Mar 2012
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pike JM, Athwal GS, Faber KJ, King GJ. Radial head fractures--an update. J Hand Surg Am. 2009 Mar;34(3):557-65. doi: 10.1016/j.jhsa.2008.12.024.
PubMed 19258159Poolman RW, Goslings JC, Lee JB, Statius Muller M, Steller EP, Struijs PA. Conservative treatment for closed fifth (small finger) metacarpal neck fractures. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003210. doi: 10.1002/14651858.CD003210.pub3.
PubMed 16034891ten Berg PW, Ring D. Patients lost to follow-up after metacarpal fractures. J Hand Surg Am. 2012 Jan;37(1):42-6. doi: 10.1016/j.jhsa.2011.08.003. Epub 2011 Oct 19.
PubMed 22015075
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optional Follow-up Visits for Common, Low-risk Arm Fractures
- ClinicalTrials.gov ID
- NCT01583556
- Acronym / sponsor ID
- 2012P000632
- Conditions
- Mallet Fracture, Metacarpal Fracture, Metacarpal Neck Fracture, Distal Radius Fracture, Radial Head Fracture
- Keywords
- Adult, English speaking, Fractures, Excellent prognosis, Upper Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 24 Apr 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.
Many common arm fractures have an excellent prognosis with little more than symptomatic treatment. When studying these fractures, investigators find that a substantial number of patients do not attend follow-up appointments. The difficulty of maneuvering in big cities, the cost of parking, the co-pay for the visit and the wait times for x-ray and doctor are all inconveniences that some patients might prefer to avoid. Building on prior research, it is appropriate to offer patients with common minor upper extremity fractures that have an excellent prognosis optional follow-up after the first visit. The plan would be to be available by phone, email and subsequent appointment at the patient's discretion if they felt that the recovery was off course. Benefit to individual participants is unlikely. The study will benefit the society as a whole, by providing a better understanding of these common fractures. It can also affect the economics of our health system by avoiding further follow-up appointments.
Primary null hypothesis: There is no difference in patient outcome 2-6 months after injury between patients that return for a second visit, and patients that do not.
Secondary null hypothesis: There is no difference in patient satisfaction 2-6 months after injury between patients that return for a second visit, and patients that do not.
Detailed description
This study will employ a prospective, non-randomized design. After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment). The alternative (Optional follow-up) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course.
Since it is up to the subject to decide whether or not he or she wants a second appointment or the brochure, it is observational rather than interventional.
Evaluation: 2-6 months after injury all patients (independent of group) will be contacted by either phone or email by a blinded research assistant and asked to provide the following: pain with NRS (scale 0-10); three satisfaction questions; disability with use of Quick DASH; and if they returned to modified and regular work.
Patients in the standard group A will return to the Hand and Upper Extremity Service for their usual practice follow-up examination 1-3 months after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | – | –This study will employ a prospective, non-randomized design. After the questionnaires are filled the patients choose whether or not to schedule a second appointment for evaluation of their fracture: The first group will be scheduled for a second visit (standard treatment) as our daily practice after 1-3 months. They will be contacted after 2-6 months either by phone or email and will complete again some questionnaires (Quick DASH, satisfaction, return to work). |
| Optional follow-up group | – | –The alternative (Optional follow-up group) will be to take a handout describing the recovery and providing instructions for how to contact us should they get off course. The questionnaires will be repeated either by phone or email in 2-6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult, English-speaking patients presenting to our outpatient clinic, that meet the inclusion criteria for this study will be invited to enroll at the time of the first visit at the outpatient clinic.
Key inclusion criteria (8 listed)
- adult (>18 years)
- English-speaking
- fracture with an excellent prognosis such as:
- nondisplaced mallet fracture
- stable, well-aligned metacarpal fracture
Key exclusion criteria (2 listed)
- pregnant women
- no written informed consent
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 Quick DASH
Time frame: Change from baseline at enrollment to follow-up at 2-6 months
The Disabilities of Arm Shoulder and Hand (DASH) questionnaire is used frequently in hand and upper extremity research to assess disability. The Quick DASH is the short version of the DASH consisting of 11 questions. http://www.dash.iwh.on.ca/system/files/quickdash_questionnaire_2010.pdf
1 secondary outcome
Satisfaction
Time frame: Change from baseline at enrollment to follow-up at 2-6 months
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 7 Apr 2015.
- Background: PubMed 19258159Pike JM, Athwal GS, Faber KJ, King GJ. Radial head fractures--an update. J Hand Surg Am. 2009 Mar;34(3):557-65. doi: 10.1016/j.jhsa.2008.12.024.
- Background: PubMed 16034891Poolman RW, Goslings JC, Lee JB, Statius Muller M, Steller EP, Struijs PA. Conservative treatment for closed fifth (small finger) metacarpal neck fractures. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003210. doi: 10.1002/14651858.CD003210.pub3.
- Background: PubMed 22015075ten Berg PW, Ring D. Patients lost to follow-up after metacarpal fractures. J Hand Surg Am. 2012 Jan;37(1):42-6. doi: 10.1016/j.jhsa.2011.08.003. Epub 2011 Oct 19.
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 principal investigator
Massachusetts General Hospital
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 Mallet Fracture and Metacarpal Fracture, run by Massachusetts General Hospital at 1 site in United States.
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 8 inclusion and 2 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 7 Apr 2015. 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 United States. 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?
Disability with use of Quick DASH (time frame: Change from baseline at enrollment to follow-up at 2-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583556, which also lists 3 linked publications.
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 7 Apr 2015.