Open Pilon Fractures Clinical Trial
Official title:
Natural History and Functional Outcome of Operatively Treated Open Pilon Fractures
Verified date | June 2017 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | April 9, 2010 |
Est. primary completion date | April 9, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Hershey Medical Center and College of Medicine | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Milton S. Hershey Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year |