Humeral FracturesHUMERUSNCT00720681
Plating of Humeral Shaft Fractures in Multiple Trauma Patients.
An observational study of Humeral Fractures and Multiple Trauma, run by OhioHealth.
Trial summary
The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Humeral Fractures, Multiple Trauma
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jan 2012
- Phase
- Observational
- 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
Study population: Patients treated by our practice for diaphyseal fracture of the humerus after multiple trauma.
Who may be able to join
- age > 18 years
- patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF)
- patients for whom the above fracture has healed
- patients willing and able to provide informed consent and able to participate in study procedures
Who cannot join
- patients with known pathological fractures
- patients with metabolic bone disease
- patients with humeral head or inter-articular surface fractures, or other upper extremity fractures
- patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.)
- patients with neurologic injury to upper extremities
About this study
Official title: Plating of Acute Humeral Diaphyseal Fractures Via an Anterior Lateral Approach in Multiple Trauma Patients.
The purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.
- Conditions
- Humeral Fractures, Multiple Trauma
- Medical subject headings
- Humeral Fractures, Multiple Trauma
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH (Disabilities of the Arm, Shoulder and Hand) Score
Measured: At Enrollment
Strength of injured arm compared to uninjured arm
Measured: At enrollment
Range of motion in injured arm compared to uninjured arm
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2009
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Humeral FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma and Reconstructive Surgery
- Responsible party
- Principal investigator, Bruce French, OhioHealth
- Investigators
- Bruce French, M.D., Principal investigator, Grant Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720681
- Sponsor's protocol ID
- 08-0014
- Acronym
- HUMERUS
- Status last verified
- Mar 2016
- First submitted
- 21 Jul 2008
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Idoine JD 3rd, French BG, Opalek JM, DeMott L. Plating of acute humeral diaphyseal fractures through an anterior approach in multiple trauma patients. J Orthop Trauma. 2012 Jan;26(1):9-18. doi: 10.1097/BOT.0b013e318214ebd5.
PubMed 21577147
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plating of Acute Humeral Diaphyseal Fractures Via an Anterior Lateral Approach in Multiple Trauma Patients.
- ClinicalTrials.gov ID
- NCT00720681
- Acronym / sponsor ID
- HUMERUS / 08-0014
- Conditions
- Humeral Fractures, Multiple Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma and Reconstructive Surgery
- Study start
- Aug 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 Jul 2008 (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 purpose of this study is to review our experience with the operative management of acute diaphyseal fractures of the humerus via an anterolateral approach with the use of small fragment fixation at a Level I, urban, trauma center. We will report our clinical and radiographic results, complication rate and final range of motion. A standardized outcome measurement (DASH) will be reported. Muscle recovery of the triceps and biceps will be evaluated by a standard protocol, accomplished with the assistance of a licensed physical therapist. We hypothesize that open reduction and internal fixation of humeral diaphyseal fractures via an antero-lateral approach with the use of small fragment fixation is a safe and efficacious way to treat multiple trauma patients with these injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated by our practice for diaphyseal fracture of the humerus after multiple trauma.
Key inclusion criteria (4 listed)
- age > 18 years
- patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF)
- patients for whom the above fracture has healed
- patients willing and able to provide informed consent and able to participate in study procedures
Key exclusion criteria (5 listed)
- patients with known pathological fractures
- patients with metabolic bone disease
- patients with humeral head or inter-articular surface fractures, or other upper extremity fractures
- patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.)
- patients with neurologic injury to upper extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DASH (Disabilities of the Arm, Shoulder and Hand) Score
Time frame: At Enrollment
Strength of injured arm compared to uninjured arm
Time frame: At enrollment
Range of motion in injured arm compared to uninjured arm
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Results publication: PubMed 21577147Idoine JD 3rd, French BG, Opalek JM, DeMott L. Plating of acute humeral diaphyseal fractures through an anterior approach in multiple trauma patients. J Orthop Trauma. 2012 Jan;26(1):9-18. doi: 10.1097/BOT.0b013e318214ebd5.
- Individual participant dataSharing planned: No
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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.
Bruce French, M.D. principal investigator
Grant Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Humeral Fractures and Multiple Trauma, run by OhioHealth.
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 5 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: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DASH (Disabilities of the Arm, Shoulder and Hand) Score (time frame: At Enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00720681, which also lists 1 linked publication.
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 30 Mar 2016.