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Functional Outcomes After Radial Head Fractures Treated Non-operatively

Functional Outcomes After Radial Head Fractures Treated Non-operatively

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03170128
Enrollment
51
Registered
2017-05-30
Start date
2014-08-03
Completion date
2017-08-01
Last updated
2017-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radial Head Fracture

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.

Interventions

PROCEDUREOutpatient physical therapy in addition to standard follow-up visits

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

BEHAVIORALHome 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

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Successful fracture union3 MonthsDemonstrated through x-rays

Secondary

MeasureTime frameDescription
Functional outcome score3 Monthsfunctional survey scores will demonstrate that physical therapy does not impact patient outcomes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026