Study Stopped
Low enrollment. Treament no longer used by researchers.
Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna
Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna
1 other identifier
interventional
13
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2010
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 30, 2011
CompletedFirst Posted
Study publicly available on registry
December 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedNovember 11, 2014
November 1, 2014
2.4 years
November 30, 2011
November 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
implant pain
a visual analog scale (VAS) will be used to assess pain in the forearm
1 year
Secondary Outcomes (1)
re-operation rate to remove painful hardware
1 year
Study Arms (2)
intramedullary nailing and plating
ACTIVE COMPARATORintramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures
plating
ACTIVE COMPARATORplating of both the radius and ulna in the treatment of both bone forearm fractures
Interventions
Surgical intramedullary nailing of the ulna and plating of the radius
Surgical plating of both bonforearm fractures
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tampa General Hospital
Tampa, Florida, 33606, United States
St Josephs Hospital
Tampa, Florida, 33607, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Sanders, MD
Florida Orthopaedic Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2011
First Posted
December 2, 2011
Study Start
September 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
November 11, 2014
Record last verified: 2014-11