Operatively Treated Open Pilon Fractures

NCT00689429 | Completed

• 2 other identifiers: DCG002IRB# 27647EP
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Open Pilon Fractures

Keywords

Pilon Fractures

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center and College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

• David C Goodspeed, MD

  Penn State Hershey Medical Center and College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 3, 2008
• Study Start: May 1, 2008
• Primary Completion: April 9, 2010
• Study Completion: April 9, 2010
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

US (1)