Fractures of Radius and UlnaNCT01484366
Forearm Shaft Fractures: Plating of Radius and Ulna Versus Plating of Radius and Nailing of Ulna
A study testing intramedullary nailing and plating and plating in people with Fractures of Radius and Ulna, run by Florida Orthopaedic Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures of Radius and Ulna
- What is being tested?
- intramedullary nailing and plating and plating
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tampa General Hospital
Tampa, Florida, 33606
St Josephs Hospital
Tampa, Florida, 33607
About this study
Official title: Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna
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.
Read the 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.
- Conditions
- Fractures of Radius and Ulna
- Being tested
- intramedullary nailing and plating, plating
- Keywords
- fractures of both radius and ulna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intramedullary nailing and platingProcedure or surgery
Also called forearm fractures
Surgical intramedullary nailing of the ulna and plating of the radius
platingProcedure or surgery
Also called Forearm fractures
Surgical plating of both bonforearm fractures
| Study group | Role | What they receive |
|---|---|---|
| intramedullary nailing and plating | Active comparator | intramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures Receives: Procedure: intramedullary nailing and plating |
| plating | Active comparator | plating of both the radius and ulna in the treatment of both bone forearm fractures Receives: Procedure: plating |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant pain
a visual analog scale (VAS) will be used to assess pain in the forearm
Measured: 1 year
Secondary outcomes (1)
re-operation rate to remove painful hardware
repeat surgical intervention will be captured
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startSep 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Low enrollment. Treament no longer used by researchers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures of Radius and UlnaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Orthopaedic Institute
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Roy Sanders, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484366
- Sponsor's protocol ID
- BBFA
- Status last verified
- Nov 2014
- First submitted
- 30 Nov 2011
- Last updated
- 11 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial for Forearm Shaft Fractures: Plating of Radius and Ulna vs. Plating of Radius and Nailing of Ulna
- ClinicalTrials.gov ID
- NCT01484366
- Acronym / sponsor ID
- BBFA
- Conditions
- Fractures of Radius and Ulna
- Keywords
- fractures of both radius and ulna
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment. Treament no longer used by researchers.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Florida Orthopaedic InstituteResearch network
- Study start
- Sep 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intramedullary nailing and plating | Active comparator | Procedure: intramedullary nailing and platingintramedullary nailing of the ulna and plating of the radius in the treatment of both bone forearm fractures |
| plating | Active comparator | Procedure: platingplating of both the radius and ulna in the treatment of both bone forearm fractures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Children under the age of 18
- Pregnancy
- Comminuted ulna fractures
- Those with associated bony elbow or wrist trauma
- Elbow dislocation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intramedullary nailing and platingAlso: forearm fracturesSurgical intramedullary nailing of the ulna and plating of the radius | Procedure or surgery | intramedullary nailing and plating |
| platingAlso: Forearm fracturesSurgical plating of both bonforearm fractures | Procedure or surgery | plating |
Primary outcome
implant pain
Time frame: 1 year
a visual analog scale (VAS) will be used to assess pain in the forearm
1 secondary outcome
re-operation rate to remove painful hardware
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Low enrollment. Treament no longer used by researchers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Sanders, MD principal investigator
Florida Orthopaedic Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intramedullary nailing and plating and plating in people with Fractures of Radius and Ulna, run by Florida Orthopaedic Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment. Treament no longer used by researchers.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.