Atrium Health- Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Location status: Recruiting
NCT Number: NCT04615104
The purpose of this study is to understand the trajectory of function and self-reported outcomes of patients following pelvic and acetabular, treated both operatively and nonoperatively.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Charlotte, North Carolina, 28203, United States
Location status: Recruiting
The goal of the study study is to prospectively capture data from patients following pelvic and acetabular fractures, treated both operatively and nonoperatively, in order to understand the trajectory of functional and self-reported outcomes as well as to answer critical questions about treatment. Performance assessment data and patient-reported outcome measures utilizing the NIH PROMIS tool will be collected and analyzed for patients following pelvic or acetabular fracture, regardless of treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
surgical treatment
nonsurgical treatment
Time frame: 0-24 months following injury
Average time to return to work and activities
Time frame: baseline, 3, 6, 12 and 24 months
The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
Time frame: 0-24 months following injury
Union rates as measured clinically and radiographically. Xrays will be collected from the electronic medical record.
Time frame: 0-24 months following injury
Rates of readmission, reoperations and complications
Time frame: 3, 6, 12 and 24 months
Participants complete a modified 10 meter walk test which involves the subject starting from a standing position, walking 5 meters at a comfortable pace, turning around, and then walking back 5 meters to the original starting point. The test is repeated twice for each subject.
Time frame: 3, 6, 12 and 24 months
Participants begin from a seated position and are directed to come to a full standing position without push off assistance from upper extremities and then return to a seated position without upper extremity assist.
Time frame: 3, 6, 12 and 24 months
Participants begin in a seated position. They are directed to stand and walk 3 meters to a cone on the floor. They are to round the cone in a continuous motion, walk back to the chair, turn again and be seated. The entire test is performed at a comfortable and safe speed for the patient.
Contact information is provided by the study sponsor or research team.
Christine Churchill, MA
CONTACT
Erica Grochowski, MS
CONTACT
Wake Forest University Health Sciences
Other
Functional, Clinical, and Performance Outcomes Following Pelvic and Acetabular Fracture: A Prospective Observational Study
Acronym: PACE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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