Functional Outcomes After Radial Head Fractures Treated Non-operatively

Not Applicable

Completed

• Conditions: Radial Head Fracture
• Interventions: Procedure: Outpatient physical therapy in addition to standard follow-up visits; Behavioral: Home exercises in addition to standard follow-up visits

• Registration Number: NCT03170128
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-03
• Primary Completion: 2016-08-01
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-30
• Status Verified: 2017-08
• Study Completion: 2017-08-01
• Last Update Submitted: 2017-08-14
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Outpatient Physical Therapy	Outpatient physical therapy in addition to standard follow-up visits	-
Home Exercises	Home exercises in addition to standard follow-up visits	-

Primary Outcome Measures

Name	Time	Method
Successful fracture union	3 Months	Demonstrated through x-rays

Secondary Outcome Measures

Name	Time	Method
Functional outcome score	3 Months	functional survey scores will demonstrate that physical therapy does not impact patient outcomes

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States