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

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.

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Key information

Conditions

Mallet Fracture Arm Injuries Distal Radius Fracture Elbow Fractures Elbow Injuries Forearm Injuries Fractures, Bone Metacarpal Fracture Metacarpal Neck Fracture Radial Head Fracture Radial Head and Neck Fractures Radius Fractures Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Apr 24, 2012
Registry last updated: Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed