Operatively Treated Open Pilon Fractures
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Purpose
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.
| Condition |
|---|
|
Open Pilon Fractures |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Natural History and Functional Outcome of Operatively Treated Open Pilon Fractures |
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult (18 years and older) patients treated with definitive open reduction and fixation of open pilon fractures between 2000 - 2007 at Hershey Medical Center.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| United States, Pennsylvania | |
| Penn State Hershey Medical Center and College of Medicine | |
| Hershey, Pennsylvania, United States, 17033 | |
| Principal Investigator: | David C Goodspeed, MD | Penn State Hershey Medical Center and College of Medicine |
More Information
No publications provided
| Responsible Party: | David C. Goodspeed, M.D., Penn State College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00689429 History of Changes |
| Other Study ID Numbers: | DCG002, IRB# 27647EP |
| Study First Received: | May 30, 2008 |
| Last Updated: | May 30, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Penn State University:
|
Pilon Fractures |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013