Functional Outcomes After Radial Head Fractures Treated Non-operatively

Study Overview
=================
Brief 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.

Official Title
-----------------
Functional Outcomes After Radial Head Fractures Treated Non-operatively

Conditions
-----------------
Radial Head Fracture

Intervention / Treatment
-----------------
* Procedure: Outpatient physical therapy in addition to standard follow-up visits
* Behavioral: Home exercises in addition to standard follow-up visits


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Outpatient Physical Therapy<br> | Procedure: Outpatient physical therapy in addition to standard follow-up visits<br>* Patients in Group 1 will be given a prescription for outpatient physical therapy.<br>|
| Active Comparator: Home Exercises<br> | Behavioral: Home exercises in addition to standard follow-up visits<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful fracture union | Demonstrated through x-rays | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome score | functional survey scores will demonstrate that physical therapy does not impact patient outcomes | 3 Months |