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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
David C. Ring, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01583556
First received: March 27, 2012
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optional Follow-up Visits for Common, Low-risk Arm Fractures

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Disability with use of Quick DASH [ Time Frame: Change from baseline at enrollment to follow-up at 2-6 months ] [ Designated as safety issue: No ]

    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:
  • Satisfaction [ Time Frame: Change from baseline at enrollment to follow-up at 2-6 months ] [ Designated as safety issue: No ]
    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

n.a.


Estimated Enrollment: 108
Study Start Date: July 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583556

Locations
United States, Massachusetts
Hand Service, Department of Orthopaedic Surgery, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: David Ring, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: David C. Ring, MD, Director of Research, Hand Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01583556     History of Changes
Other Study ID Numbers: 2012P000632
Study First Received: March 27, 2012
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Adult
English speaking
Fractures
Excellent prognosis
Upper Extremity

Additional relevant MeSH terms:
Fractures, Bone
Radius Fractures
Wounds and Injuries
Forearm Injuries
Arm Injuries

ClinicalTrials.gov processed this record on August 20, 2014