Optional Follow-up Visits for Common, Low-risk Arm Fractures

Completed

• Conditions: Metacarpal Fracture; Metacarpal Neck Fracture; Radial Head Fracture; Mallet Fracture; Distal Radius Fracture

• Registration Number: NCT01583556
• Lead Sponsor: Massachusetts General Hospital

Brief 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. 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 Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-24
• Study Start: 2012-07
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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

Exclusion Criteria

• pregnant women
• no written informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability with use of Quick DASH	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

Secondary Outcome Measures

Name	Time	Method
Satisfaction	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.

Trial Locations

Locations (1)

Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States