Open Pilon FracturesNCT00689429
Operatively Treated Open Pilon Fractures
An observational study of Open Pilon Fractures, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
A chart review will be performed to extrapolate information including sex, height, weight, date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage, surgical history, wound history, fracture healing, and length of time to return to work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Pilon Fractures
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 9 Apr 2010
- 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: Adult (18 years and older) patients treated with definitive open reduction and fixation of open pilon fractures between 2000 - 2007 at Hershey Medical Center.
Who may be able to join
- Patients admitted to the Hershey Medical Center with a primary diagnosis of an open pilon fracture and surgically treated between 1/1/2000 and 12/31/2007.
- Temporization of the fracture may be performed elsewhere or by other orthopaedists at the Hershey Medical Center. Definitive surgery must be performed by Dr.'s David Goodspeed, J. Spence Reid, or Robert Simpson.
Who cannot join
- closed pilon fracture or pathological fracture; definitive fracture fixation performed outside the Hershey Medical center or by a surgeon other than Dr.'s David Goodspeed, J. Spence Reid, and Robert Simpson; patient is diagnosed with active infection at the time of first surgery at the Penn State Hershey Medical Center; patient is less than 18 years of age at the time of definitive surgery;
- patient is mentally compromised and unable to give consent;
- does not cooperate with survey data acquisition; patient is deceased;
- patient presented with significant ipsilateral leg fracture or injury at anytime within the time frame of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center and College of Medicine
Hershey, Pennsylvania, 17033
About this study
Official title: Natural History and Functional Outcome of Operatively Treated Open Pilon Fractures
A chart review will be performed to extrapolate information including sex, height, weight, date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage, surgical history, wound history, fracture healing, and length of time to return to work. Dr.'s Goodspeed and Reid will conduct a radiographic review independently for each subject, classifying all fractures according to the Orthopaedic Trauma Association classification guide. If a discrepancy in classification is found, then both will discuss together and come to a consensus.
Read the detailed description
After patients are identified with the Orthopaedic Surgical Database, letters will be sent to those patients who meet inclusion/exclusion criteria informing them of the study and that they will be contacted by the research associate in 1-2 weeks. The research associate will telephone the patient to discuss the study and answer any questions they may have. Dr. Goodspeed will also be available to answer any questions. The research associate with obtain verbal consent and proceed by asking questions from the Short Musculoskeletal Function Assessment Injury and Arthritis Survey, and the Foot and Ankle Outcomes Questionnaire. The medical student will then perform a chart review to extrapolate information including sex, height, weight, date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage, surgical history, wound history, fracture healing, and length of time to return to work. Dr.'s Goodspeed and Reid will conduct a radiographic review independently for each subject, classifying all fractures according to the Orthopaedic Trauma Association classification guide. If a discrepancy in classification is found, then both will discuss together and come to a consensus.
Functional outcomes data will be measured by the Short Musculoskeletal Function Assessment Injury and Arthritis Survey and the Foot and Ankle Outcomes Questionnaire. Radiographic Classifications will be determined according to the Orthopaedic Trauma Association's classification guide.
- Conditions
- Open Pilon Fractures
- Keywords
- Pilon Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcomes data will be measured by the Short Musculoskeletal Function Assessment Injury and Arthritis Survey and the Foot and Ankle Outcomes Questionnaire. Radiographic Classifications will be determined.
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 posted3 Jun 2008 (estimated)
- Study startMay 2008
- Primary completion9 Apr 2010
- Study completion9 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Pilon 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 37 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 Hershey Medical Center and College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689429
- Sponsor's protocol ID
- DCG002
- Other IDs
- IRB# 27647EP
- Status last verified
- Jun 2017
- First submitted
- 30 May 2008
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Functional Outcome of Operatively Treated Open Pilon Fractures
- ClinicalTrials.gov ID
- NCT00689429
- Acronym / sponsor ID
- DCG002
- Conditions
- Open Pilon Fractures
- Keywords
- Pilon Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- 9 Apr 2010 (actual)
- Study completion
- 9 Apr 2010 (actual)
- First posted
- 3 Jun 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.
A chart review will be performed to extrapolate information including sex, height, weight, date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage, surgical history, wound history, fracture healing, and length of time to return to work. Dr.'s Goodspeed and Reid will conduct a radiographic review independently for each subject, classifying all fractures according to the Orthopaedic Trauma Association classification guide. If a discrepancy in classification is found, then both will discuss together and come to a consensus.
Detailed description
After patients are identified with the Orthopaedic Surgical Database, letters will be sent to those patients who meet inclusion/exclusion criteria informing them of the study and that they will be contacted by the research associate in 1-2 weeks. The research associate will telephone the patient to discuss the study and answer any questions they may have. Dr. Goodspeed will also be available to answer any questions. The research associate with obtain verbal consent and proceed by asking questions from the Short Musculoskeletal Function Assessment Injury and Arthritis Survey, and the Foot and Ankle Outcomes Questionnaire. The medical student will then perform a chart review to extrapolate information including sex, height, weight, date/time admitted to HMC, injury data, comorbidities, fracture pattern, antibiotic usage, surgical history, wound history, fracture healing, and length of time to return to work. Dr.'s Goodspeed and Reid will conduct a radiographic review independently for each subject, classifying all fractures according to the Orthopaedic Trauma Association classification guide. If a discrepancy in classification is found, then both will discuss together and come to a consensus.
Functional outcomes data will be measured by the Short Musculoskeletal Function Assessment Injury and Arthritis Survey and the Foot and Ankle Outcomes Questionnaire. Radiographic Classifications will be determined according to the Orthopaedic Trauma Association's classification guide.
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
- Adult (18 years and older) patients treated with definitive open reduction and fixation of open pilon fractures between 2000 - 2007 at Hershey Medical Center.
Key inclusion criteria (2 listed)
- Patients admitted to the Hershey Medical Center with a primary diagnosis of an open pilon fracture and surgically treated between 1/1/2000 and 12/31/2007.
- Temporization of the fracture may be performed elsewhere or by other orthopaedists at the Hershey Medical Center. Definitive surgery must be performed by Dr.'s David Goodspeed, J. Spence Reid, or Robert Simpson.
Key exclusion criteria (4 listed)
- closed pilon fracture or pathological fracture; definitive fracture fixation performed outside the Hershey Medical center or by a surgeon other than Dr.'s David Goodspeed, J. Spence Reid, and Robert Simpson; patient is diagnosed with active infection at the time of first surgery at the Penn State Hershey Medical Center; patient is less than 18 years of age at the time of definitive surgery;
- patient is mentally compromised and unable to give consent;
- does not cooperate with survey data acquisition; patient is deceased;
- patient presented with significant ipsilateral leg fracture or injury at anytime within the time frame of the study.
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
Functional outcomes data will be measured by the Short Musculoskeletal Function Assessment Injury and Arthritis Survey and the Foot and Ankle Outcomes Questionnaire. Radiographic Classifications will be determined.
Time frame: 1 year
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 20 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 Hershey Medical Center and College of Medicine
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 Open Pilon Fractures, 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 4 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 20 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.
What does the primary outcome measure?
Functional outcomes data will be measured by the Short Musculoskeletal Function Assessment Injury and Arthritis Survey and the Foot and Ankle Outcomes Questionnaire. Radiographic Classifications will be determined. (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 20 Jun 2017.