Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna
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ClinicalTrials.gov Identifier: NCT01484366 |
Recruitment Status :
Terminated
(Low enrollment. Treament no longer used by researchers.)
First Posted : December 2, 2011
Last Update Posted : November 11, 2014
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The hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points:
- a lower rate of implant pain
- a lower re-operation rate to remove painful hardware.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fractures of Radius and Ulna | Procedure: intramedullary nailing and plating Procedure: plating | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |
Arm | Intervention/treatment |
---|---|
Active Comparator: intramedullary nailing and plating
intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures
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Procedure: intramedullary nailing and plating
Surgical intramedullary nailing of the ulna and plating of the radius
Other Name: forearm fractures |
Active Comparator: plating
plating of both the radius and ulna in the treatment of both bone forearm fractures
|
Procedure: plating
Surgical plating of both bonforearm fractures
Other Name: Forearm fractures |
- implant pain [ Time Frame: 1 year ]a visual analog scale (VAS) will be used to assess pain in the forearm
- re-operation rate to remove painful hardware [ Time Frame: 1 year ]repeat surgical intervention will be captured

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diaphyseal fractures of both radius and ulna
- Ulna fractures that are oblique or transverse
- Fractures may be closed or Grade I-IIIA open
- Patients must be over 18 and skeletally mature
Exclusion Criteria:
- Children under the age of 18
- Pregnancy
- Comminuted ulna fractures
- Those with associated bony elbow or wrist trauma
- Elbow dislocation
- Subjects with bone pathology (osteoporosis, OI, Paget's disease, bone cancer)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484366
United States, Florida | |
Tampa General Hospital | |
Tampa, Florida, United States, 33606 | |
St Josephs Hospital | |
Tampa, Florida, United States, 33607 |
Principal Investigator: | Roy Sanders, MD | Florida Orthopaedic Institute |
Responsible Party: | Florida Orthopaedic Institute |
ClinicalTrials.gov Identifier: | NCT01484366 History of Changes |
Other Study ID Numbers: |
BBFA |
First Posted: | December 2, 2011 Key Record Dates |
Last Update Posted: | November 11, 2014 |
Last Verified: | November 2014 |
Keywords provided by Florida Orthopaedic Institute:
fractures of both radius and ulna |
Additional relevant MeSH terms:
Fractures, Bone Radius Fractures Ulna Fractures |
Wounds and Injuries Forearm Injuries Arm Injuries |