Optional Follow-up Visits for Common, Low-risk Arm Fractures
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|ClinicalTrials.gov Identifier: NCT01583556|
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : April 7, 2015
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.
|Condition or disease|
|Mallet Fracture Metacarpal Fracture Metacarpal Neck Fracture Distal Radius Fracture Radial Head Fracture|
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 Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Optional Follow-up Visits for Common, Low-risk Arm Fractures|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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.
- 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.
- Satisfaction [ Time Frame: Change from baseline at enrollment to follow-up at 2-6 months ]The investigators measure the overall current patient satisfaction with an ordinal scale from 0 to 10, 0 being completely dissatisfied, 10 being completely satisfied.
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583556
|United States, Massachusetts|
|Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||David Ring, MD||Massachusetts General Hospital|