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Functional Outcomes After Radial Head Fractures Treated Non-operatively

NCT03170128 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2017-08-17

No results posted yet for this study

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.

Conditions

  • Radial Head Fracture

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kenneth Egol, MD · NYU Hospital for Joint Diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-03
Primary Completion
2016-08-01
Completion
2017-08-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03170128 on ClinicalTrials.gov