Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Florida Orthopaedic Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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:

  1. a lower rate of implant pain
  2. 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

Detailed Description:
This is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. implant pain [ Time Frame: 1 year ]
    a visual analog scale (VAS) will be used to assess pain in the forearm


Secondary Outcome Measures :
  1. re-operation rate to remove painful hardware [ Time Frame: 1 year ]
    repeat surgical intervention will be captured


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
St Josephs Hospital
Tampa, Florida, United States, 33607
Sponsors and Collaborators
Florida Orthopaedic Institute
Investigators
Layout table for investigator information
Principal Investigator: Roy Sanders, MD Florida Orthopaedic Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Florida Orthopaedic Institute
ClinicalTrials.gov Identifier: NCT01484366    
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:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries