Acetabular FracturesNCT00676611
Acetabular Fractures of Both Columns
An observational study of Acetabular Fractures and Both Columns, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The purpose of this research is to study a specific acetabular (hip socket) fracture pattern and how its treatment affects the functional, clinical, and x-ray outcomes. There are no experimental procedures involved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acetabular Fractures, Both Columns
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 28 Feb 2014
- 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 study will include 10 patients who have had column fractures with an associated posterior wall fracture or significantly displaced posterior column fracture that required a separate approach for reduction and/or fixation of the hip performed at Hershey Medical Center by two surgeons, Drs. David Goodspeed and J. Spence Reid over a 12 month period (June 2006 - May 2007). There is no control population.
Who may be able to join
- All patients that underwent surgical fixation of the hip at Hershey Medical Center between June 2006 and May 2007 by Dr's J. Spence Reid and David Goodspeed.
- They will include patients that are admitted directly from the field or are transferred from outside hospitals.
Who cannot join
- will be those acetabular fractures of non-traumatic etiology (e.g.: secondary to malignancy or fatigue)
- fractures that have not undergone operative fixation
- pediatric populations under the age of 18
- mentally compromised patients
- those that do not give consent for the clinical evaluation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Both Column Acetabular Fractures With Associated Posterior Deformity Patterns: Implications for Surgical Treatment and Prognosis
The purpose of this research is to study a specific acetabular (hip socket) fracture pattern and how its treatment affects the functional, clinical, and x-ray outcomes. There are no experimental procedures involved.
Read the detailed description
This study will identify a small subset of patients that fall outside the Letournel classification system of acetabular fractures. The fracture pattern, its influence on the surgical treatment decision making process, and the radiographic and outcomes will be detailed. In particular, both-column acetabular fractures with significant posterior deformity have been correlated with poor functional outcomes, increased arthritis radiographically, and worse prognosis in general. Despite these findings, there has been no specific study evaluating these injury patterns to date. We present ten patients with both column acetabular fractures and an associated posterior column/wall piece and their clinical outcomes in an effort to help guide surgical treatment and offer prognostic guidance.
- Conditions
- Acetabular Fractures, Both Columns
- Keywords
- Acetabular Fractures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startMay 2008
- Primary completion28 Feb 2014
- Study completion28 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular FracturesStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David C Goodspeed, MD, Principal investigator, Penn State Milton S. Hershey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676611
- Sponsor's protocol ID
- DCG001
- Other IDs
- IRB# 27556EP
- Status last verified
- Jun 2017
- First submitted
- 8 May 2008
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Both Column Acetabular Fractures With Associated Posterior Deformity Patterns: Implications for Surgical Treatment and Prognosis
- ClinicalTrials.gov ID
- NCT00676611
- Acronym / sponsor ID
- DCG001
- Conditions
- Acetabular Fractures, Both Columns
- Keywords
- Acetabular Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- 28 Feb 2014 (actual)
- Study completion
- 28 Feb 2014 (actual)
- First posted
- 13 May 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 research is to study a specific acetabular (hip socket) fracture pattern and how its treatment affects the functional, clinical, and x-ray outcomes. There are no experimental procedures involved.
Detailed description
This study will identify a small subset of patients that fall outside the Letournel classification system of acetabular fractures. The fracture pattern, its influence on the surgical treatment decision making process, and the radiographic and outcomes will be detailed. In particular, both-column acetabular fractures with significant posterior deformity have been correlated with poor functional outcomes, increased arthritis radiographically, and worse prognosis in general. Despite these findings, there has been no specific study evaluating these injury patterns to date. We present ten patients with both column acetabular fractures and an associated posterior column/wall piece and their clinical outcomes in an effort to help guide surgical treatment and offer prognostic guidance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 10 patients who have had column fractures with an associated posterior wall fracture or significantly displaced posterior column fracture that required a separate approach for reduction and/or fixation of the hip performed at Hershey Medical Center by two surgeons, Drs. David Goodspeed and J. Spence Reid over a 12 month period (June 2006 - May 2007). There is no control population.
Key inclusion criteria (2 listed)
- All patients that underwent surgical fixation of the hip at Hershey Medical Center between June 2006 and May 2007 by Dr's J. Spence Reid and David Goodspeed.
- They will include patients that are admitted directly from the field or are transferred from outside hospitals.
Key exclusion criteria (5 listed)
- will be those acetabular fractures of non-traumatic etiology (e.g.: secondary to malignancy or fatigue)
- fractures that have not undergone operative fixation
- pediatric populations under the age of 18
- mentally compromised patients
- those that do not give consent for the clinical evaluation.
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 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 19 Jun 2017.
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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.
David C Goodspeed, MD principal investigator
Penn State Milton S. Hershey
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 Acetabular Fractures and Both Columns, run by Milton S. Hershey Medical Center 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 2 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 19 Jun 2017. 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.
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 19 Jun 2017.