Functional Outcomes After Radial Head Fractures Treated Non-operatively

NCT03170128 | Completed

• 1 other identifier: 12-03464
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Radial Head Fracture

Outcome Measures

Primary Outcomes (1)

• Successful fracture union

  Demonstrated through x-rays

  3 Months

Secondary Outcomes (1)

• Functional outcome score

  3 Months

Study Arms (2)

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

Interventions

Outpatient physical therapy in addition to standard follow-up visits PROCEDURE

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

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

Home Exercises

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Radial Head and Neck Fractures

Condition Hierarchy (Ancestors)

Elbow Fractures; Elbow Injuries; Arm Injuries; Wounds and Injuries; Radius Fractures; Forearm Injuries; Fractures, Bone

Study Officials

• Kenneth Egol, MD

  NYU Hospital for Joint Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 30, 2017
• Study Start: August 3, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 17, 2017

Record last verified: 2017-08

Locations

US (1)