Clavicle FractureNCT01405703
Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures
An observational study of Clavicle Fracture, run by University of Utah at 1 site in United States.
Trial summary
This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Clavicle Fracture
- What is being tested?
- xrays
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to May 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated surgically for diaphysial clavicle fracture.
Who may be able to join
- 18 years of age or older
- displaced (i.e., no cortical contact of fracture ends on two xray view) diaphyseal clavicle fracture
- fracture pattern amenable to plate fixation
- neurologic injury requiring open reduction
- open clavicle fracture
- clavicle nonunion (defined as an absence of radiographic bony union in the presence of neurologic, cosmetic, or functional complaints at six months duration
- symptomatic malunion (defined as a healed, but shortened or angulated fracture in the presence of neurologic, cosmetic, or functional complaints)
- clavicle fracture associated with a scapular of humeral fracture (floating shoulder)
Who cannot join
- a nondisplaced or minimally displaced closed, neurovascularly intact clavicle fracture
- fracture of the medial or lateral end of the clavicle
- pathological fracture
- patient is unable to medically tolerate general anesthesia
- patient is unable to provide informed consent or comply with completing questionnaires
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopedic Center
Salt Lake City, Utah, 84121
About this study
This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the principle investigators (PI's) standard of care for this injury. Measurements and questionnaires are related to the study.
- Conditions
- Clavicle Fracture
- Being tested
- xrays
- Keywords
- Clavicle Fractures, Numbness, Percutaneous plate fixation, open plate fixation, incision related numbness, union rates, subjective, questionnaire based outcomes, Diaphyseal
- Medical subject headings
- Hypesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xraysOther
xrays from 2 week postop to 5 year postop
| Study group | Role | What they receive |
|---|---|---|
| percuataneous plate fixation | an approach with three small longitudinal incisions Receives: Other: xrays | |
| open plate fixation | large transverse incision Receives: Other: xrays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score
The primary outcome measure for this study will be incision related numbness, based on clinical examination and the use of our skin numbness map. Our null hypothesis is that there will be no difference in incision related numbness between the two groups: percutaneous versus open approach. Our primary objective is to disprove this hypothesis, predicting that the percutaneously treated group will have less incisional numbness.
Measured: 1+ year post-op
Secondary outcomes (1)
Incision numbness at surgical site.
Our secondary outcome measures will be union, malunion, and nonunion rates between these two methods, as well as infection rates and functional and satisfaction outcomes based on subjective questioning and the DASH and Constant shoulder score questionnaires. Our null hypothesis for these secondary outcomes is that there will be no difference between the two treatment groups.
Measured: 2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Kubiak, University of Utah
- Investigators
- Erik Kubiak, MD, Principal investigator, University of UtahThomas Christensen, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405703
- Sponsor's protocol ID
- 36814
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2011
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures
- ClinicalTrials.gov ID
- NCT01405703
- Acronym / sponsor ID
- 36814
- Conditions
- Clavicle Fracture
- Keywords
- Clavicle Fractures, Numbness, Percutaneous plate fixation, open plate fixation, incision related numbness, union rates, subjective, questionnaire based outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Jul 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.
This is a prospective, level II evidence comparison between two cohorts. This study is designed to compare the percutaneous versus open approach for plate fixation of diaphyseal clavicle fractures. This study includes questionnaires and measurements that will collect data on incision-related numbness, union rates, overall outcomes, complication rates of the two methods, infection rates, and overall satisfaction. The surgical procedure, all radiographs and follow-up visits to a minimum of one year are the principle investigators (PI's) standard of care for this injury. Measurements and questionnaires are related to the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percuataneous plate fixation | – | Other: xraysan approach with three small longitudinal incisions |
| open plate fixation | – | Other: xrayslarge transverse incision |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated surgically for diaphysial clavicle fracture.
Key inclusion criteria (8 listed)
- 18 years of age or older
- displaced (i.e., no cortical contact of fracture ends on two xray view) diaphyseal clavicle fracture
- fracture pattern amenable to plate fixation
- neurologic injury requiring open reduction
- open clavicle fracture
Key exclusion criteria (5 listed)
- a nondisplaced or minimally displaced closed, neurovascularly intact clavicle fracture
- fracture of the medial or lateral end of the clavicle
- pathological fracture
- patient is unable to medically tolerate general anesthesia
- patient is unable to provide informed consent or comply with completing questionnaires
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 |
|---|---|---|
| xraysxrays from 2 week postop to 5 year postop | Other | open plate fixation, percuataneous plate fixation |
Primary outcome
Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score
Time frame: 1+ year post-op
The primary outcome measure for this study will be incision related numbness, based on clinical examination and the use of our skin numbness map. Our null hypothesis is that there will be no difference in incision related numbness between the two groups: percutaneous versus open approach. Our primary objective is to disprove this hypothesis, predicting that the percutaneously treated group will have less incisional numbness.
1 secondary outcome
Incision numbness at surgical site.
Time frame: 2 wks, 6 wks, 3 mths, 6mnths and 1+ year post-op
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 9 Jul 2015.
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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.
Erik Kubiak, MD principal investigator
University of Utah
Thomas Christensen, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clavicle Fracture, run by University of Utah at 1 site 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 8 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 9 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Functional outcome as measured by Constant Shoulder Score and Disabilities of the Arm, Shoulder and Hand (DASH) score (time frame: 1+ year post-op). 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 9 Jul 2015.