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

This study is currently recruiting participants.
Verified April 2012 by Florida Orthopaedic Institute
Sponsor:
Information provided by (Responsible Party):
Florida Orthopaedic Institute
ClinicalTrials.gov Identifier:
NCT01484366
First received: November 30, 2011
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Fractures of Radius and Ulna
 Procedure: intramedullary nailing and plating
Procedure: plating

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Florida Orthopaedic Institute:

Primary Outcome Measures:
  • implant pain [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    a visual analog scale (VAS) will be used to assess pain in the forearm


Secondary Outcome Measures:
  • re-operation rate to remove painful hardware [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    repeat surgical intervention will be captured


Estimated Enrollment: 90
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484366

Locations
United States, Florida
Tampa General Hospital Active, not recruiting
Tampa, Florida, United States, 33606
St Josephs Hospital Recruiting
Tampa, Florida, United States, 33607
Contact: Barbara Steverson, RN. MHA     813-253-2068     bsteverson@floridaortho.com    
Contact: Mary Miller, RN     813 253 2068     mmiller@floridaortho.com    
Principal Investigator: Roy Sanders, MD            
Sponsors and Collaborators
Florida Orthopaedic Institute
Investigators
Principal Investigator: Roy Sanders, MD Florida Orthopaedic Institute
  More Information

No publications provided

Responsible Party: Florida Orthopaedic Institute
ClinicalTrials.gov Identifier: NCT01484366     History of Changes
Other Study ID Numbers: BBFA
Study First Received: November 30, 2011
Last Updated: April 2, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013