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Functional Outcomes After Radial Head Fractures Treated Non-operatively

Primary Purpose

Radial Head Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outpatient physical therapy in addition to standard follow-up visits
Home exercises in addition to standard follow-up visits
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radial Head Fracture

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Outpatient Physical Therapy

Home Exercises

Arm Description

Outcomes

Primary Outcome Measures

Successful fracture union
Demonstrated through x-rays

Secondary Outcome Measures

Functional outcome score
functional survey scores will demonstrate that physical therapy does not impact patient outcomes

Full Information

First Posted
May 26, 2017
Last Updated
August 14, 2017
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03170128
Brief Title
Functional Outcomes After Radial Head Fractures Treated Non-operatively
Official Title
Functional Outcomes After Radial Head Fractures Treated Non-operatively
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 3, 2014 (Actual)
Primary Completion Date
August 1, 2016 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radial Head Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient Physical Therapy
Arm Type
Active Comparator
Arm Title
Home Exercises
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Outpatient physical therapy in addition to standard follow-up visits
Intervention Description
Patients in Group 1 will be given a prescription for outpatient physical therapy.
Intervention Type
Behavioral
Intervention Name(s)
Home exercises in addition to standard follow-up visits
Intervention Description
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
Primary Outcome Measure Information:
Title
Successful fracture union
Description
Demonstrated through x-rays
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Functional outcome score
Description
functional survey scores will demonstrate that physical therapy does not impact patient outcomes
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Egol, MD
Organizational Affiliation
NYU Hospital for Joint Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Functional Outcomes After Radial Head Fractures Treated Non-operatively

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