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OpenTrials
Completed

NCT Number: NCT03170128

Functional Outcomes After Radial Head Fractures Treated Non-operatively

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Outpatient physical therapy in addition to standard follow-up visits

Procedure

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

Home exercises in addition to standard follow-up visits

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

Primary outcomes

  1. Successful fracture union

    Time frame: 3 Months

    Demonstrated through x-rays

Secondary outcomes

  1. Functional outcome score

    Time frame: 3 Months

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 30, 2017
Registry last updated
Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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