Functional Outcomes After Radial Head Fractures Treated Non-operatively

Radial Head Fracture Clinical Trial

Official title:

Functional Outcomes After Radial Head Fractures Treated Non-operatively

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170128
• Other study ID #: 12-03464
• Status: Completed
• Phase: N/A
• First received: May 26, 2017
• Last updated: August 14, 2017
• Start date: August 3, 2014
• Est. completion date: August 1, 2017

Study information

• Verified date: August 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of physical therapy as part of the non-operative treatment of radial head fractures.There is currently no data to support the use of physical therapy in the non-operative treatment of radial head fractures. Likewise, there is no data that shows that physical therapy is harmful to patients being treated non-operatively for radial head fractures. Investigators believe that prescribing physical therapy for patients with non-displaced radial head fractures treated non-operatively is unnecessary, and that that it would be equally efficacious to teach patients simple stretching exercises that they could perform by themselves. Subjects will be randomized into 2 groups: Group 1 - Patients will be prescribed physical therapy within the first month following fracture; Group 2 - Patients will be given simple stretching exercises to perform at home and will not be given a prescription for physical therapy. Patients who agree to participate in this study and sign the informed consent will be randomly assigned to one of the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Individuals to be approached for participation in this study will include all adult (age > 18 years old) patients who are receiving or seeking medical care in the outpatient setting.

Exclusion Criteria:

• Patients who are initially determined to need surgical fixation of a radial head fracture will not be included in this study. There are no additional exclusion criteria.

Related Conditions & MeSH terms

• Fractures, Bone
• Radial Head Fracture
• Radius Fractures

Intervention

Procedure:
• Outpatient physical therapy in addition to standard follow-up visits
Patients in Group 1 will be given a prescription for outpatient physical therapy.

Behavioral:
• Home exercises in addition to standard follow-up visits
Patients in Group 2 will be carefully instructed on home exercises for range of motion and strengthening of their affected elbow. All therapy regimens will be prescribed at initial presentation, as is the current practice. All other care will be identical for patients in both groups. This

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful fracture union	Demonstrated through x-rays	3 Months
Secondary	Functional outcome score	functional survey scores will demonstrate that physical therapy does not impact patient outcomes	3 Months