Radial Head FractureNCT03170128
Functional Outcomes After Radial Head Fractures Treated Non-operatively
A study testing Outpatient physical therapy in addition to standard follow-up visits and Home exercises in addition to standard follow-up visits in people with Radial Head Fracture, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Radial Head Fracture
- What is being tested?
- Outpatient physical therapy in addition to standard follow-up visits and Home exercises in addition to standard follow-up visits
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2014to 1 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Being tested
- Outpatient physical therapy in addition to standard follow-up visits, Home exercises in addition to standard follow-up visits
- Medical subject headings
- Radial Head and Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient physical therapy in addition to standard follow-up visitsProcedure or surgery
Patients in Group 1 will be given a prescription for outpatient physical therapy.
Home exercises in addition to standard follow-up visitsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Physical Therapy | Active comparator | Not described Receives: Procedure: Outpatient physical therapy in addition to standard follow-up visits |
| Home Exercises | Active comparator | Not described Receives: Behavioral: Home exercises in addition to standard follow-up visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful fracture union
Demonstrated through x-rays
Measured: 3 Months
Secondary outcomes (1)
Functional outcome score
functional survey scores will demonstrate that physical therapy does not impact patient outcomes
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start3 Aug 2014
- Primary completion1 Aug 2016
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Head FractureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth Egol, MD, Principal investigator, NYU Hospital for Joint Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170128
- Sponsor's protocol ID
- 12-03464
- Status last verified
- Aug 2017
- First submitted
- 26 May 2017
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes After Radial Head Fractures Treated Non-operatively
- ClinicalTrials.gov ID
- NCT03170128
- Acronym / sponsor ID
- 12-03464
- Conditions
- Radial Head Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 3 Aug 2014 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Physical Therapy | Active comparator | Procedure: Outpatient physical therapy in addition to standard follow-up visits |
| Home Exercises | Active comparator | Behavioral: Home exercises in addition to standard follow-up visits |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient physical therapy in addition to standard follow-up visitsPatients in Group 1 will be given a prescription for outpatient physical therapy. | Procedure or surgery | Outpatient Physical Therapy |
| Home exercises in addition to standard follow-up visitsPatients 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 | Behavioural | Home Exercises |
Primary outcome
Successful fracture union
Time frame: 3 Months
Demonstrated through x-rays
1 secondary outcome
Functional outcome score
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
Related trials for Radial Head Fracture
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Recruiting
The Utilization of Ultrasound to Diagnose Pediatric Elbow Fractures
Elbow Pain, Supracondylar Humerus Fracture
Recruiting
Opioid-Free Pain Treatment in Trauma Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Egol, MD principal investigator
NYU Hospital for Joint Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient physical therapy in addition to standard follow-up visits and Home exercises in addition to standard follow-up visits in people with Radial Head Fracture, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful fracture union (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.