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

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583556
• Other study ID #: 2012P000632
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: April 6, 2015
• Start date: July 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Distal Radius Fracture
• Fractures, Bone
• Mallet Fracture
• Metacarpal Fracture
• Metacarpal Neck Fracture
• Radial Head Fracture
• Radius Fractures

Locations

Country	Name	City	State
United States	Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Poolman 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;(3):CD003210. Review. — View Citation

ten 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline at enrollment to follow-up at 2-6 months	No
Secondary	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.	Change from baseline at enrollment to follow-up at 2-6 months	No