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

NCT01583556 | Completed DMC

• 1 other identifier: 2012P000632
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mallet Fracture; Metacarpal Fracture; Metacarpal Neck Fracture; Distal Radius Fracture; Radial Head Fracture

Keywords

Adult; English speaking; Fractures; Excellent prognosis; Upper Extremity

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Satisfaction

  Change from baseline at enrollment to follow-up at 2-6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• pregnant women
• no written informed consent

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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.

  PMID: 19258159 BACKGROUND

• 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;2005(3):CD003210. doi: 10.1002/14651858.CD003210.pub3.

  PMID: 16034891 BACKGROUND

• 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.

  PMID: 22015075 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures; Radial Head and Neck Fractures; Fractures, Bone

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Elbow Fractures; Elbow Injuries; Radius Fractures; Forearm Injuries

Study Officials

• David Ring, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research, Hand Service

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 24, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)