Scapula FractureNCT00849771
Operative Versus Nonoperative Treatment for Scapula Fractures
An observational study of Scapula Fracture and Clavicle Fracture, run by Vanderbilt University at 1 site in United States.
Trial summary
The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scapula Fracture, Clavicle Fracture
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2009
- 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: The subject population will include patients seen at participating facilities for the care of scapula fractures, who are 18 years of age or older, meet inclusion/exclusion criteria and are willing to consent.
Who may be able to join
- 18 Years of Age or Older
- Displacement of glenoid neck and scapula body of greater than 2 cm
- Angular deformity between the fracture fragments of greater than 45 degrees.
- A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees
- A glenopolar angle less than 22 degrees
- A Double Lesion of the Superior Shoulder Suspensory Complex (SSSC)
Who cannot join
- Age Less Than 18 years Old
- Brachial Plexus Injury
- Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation
- Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage
- Ipsilateral Upper Extremity Injury
- Previous Shoulder Surgery
- Insufficient English proficiency to complete the DASH Questionnaire
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center
Nashville, Tennessee, 37232-8774
About this study
Official title: Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures
The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts.
The potential impact is a clearer set of choices in treatment options for this type of injury.
- Conditions
- Scapula Fracture, Clavicle Fracture
- Keywords
- Displaced Scapula Fracture, Scapula Fracture, Extraarticular Scapula Fractures, Clavicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Operative Treatment (Open Reduction Internal Fixation) | |
| 2 | Non-operative/Conservative Care |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startMar 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Joined another larger group of same study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapula FractureStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Obremskey, Vanderbilt University
- Investigators
- William T. Obremskey, MD, MPH, Principal investigator, Vanderbilt University Medical CenterPeter Cole, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849771
- Sponsor's protocol ID
- 080160
- Status last verified
- Nov 2015
- First submitted
- 20 Feb 2009
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures
- ClinicalTrials.gov ID
- NCT00849771
- Acronym / sponsor ID
- 080160
- Conditions
- Scapula Fracture, Clavicle Fracture
- Keywords
- Displaced Scapula Fracture, Scapula Fracture, Extraarticular Scapula Fractures, Clavicle
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Joined another larger group of same study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 24 Feb 2009 (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 contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts.
The potential impact is a clearer set of choices in treatment options for this type of injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Operative Treatment (Open Reduction Internal Fixation) |
| 2 | – | –Non-operative/Conservative Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will include patients seen at participating facilities for the care of scapula fractures, who are 18 years of age or older, meet inclusion/exclusion criteria and are willing to consent.
Key inclusion criteria (6 listed)
- 18 Years of Age or Older
- Displacement of glenoid neck and scapula body of greater than 2 cm
- Angular deformity between the fracture fragments of greater than 45 degrees.
- A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees
- A glenopolar angle less than 22 degrees
Key exclusion criteria (7 listed)
- Age Less Than 18 years Old
- Brachial Plexus Injury
- Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation
- Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage
- Ipsilateral Upper Extremity Injury
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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.
William T. Obremskey, MD, MPH principal investigator
Vanderbilt University Medical Center
Peter Cole, MD principal investigator
University of Minnesota
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 Scapula Fracture and Clavicle Fracture, run by Vanderbilt University 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 6 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Nov 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 was withdrawn before enrolling participants, so there are no results.
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.
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 13 Nov 2015.