Functional Outcomes After Radial Head Fractures Treated Non-operatively

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-03

Study Completion Date

2017-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Radial Head Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Outpatient Physical Therapy

Group Type ACTIVE_COMPARATOR

Outpatient physical therapy in addition to standard follow-up visits

Intervention Type PROCEDURE

Patients in Group 1 will be given a prescription for outpatient physical therapy.

Home Exercises

Group Type ACTIVE_COMPARATOR

Home exercises in addition to standard follow-up visits

Intervention Type BEHAVIORAL

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

Interventions

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Outpatient physical therapy in addition to standard follow-up visits

Patients in Group 1 will be given a prescription for outpatient physical therapy.

Intervention Type PROCEDURE

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No