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Pelvic and Acetabular Fracture: A Prospective Observational Study

Functional, Clinical, and Performance Outcomes Following Pelvic and Acetabular Fracture: A Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04615104
Acronym
PACE
Enrollment
200
Registered
2020-11-04
Start date
2020-01-01
Completion date
2029-12-31
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Fracture, Acetabular Fracture, Pubic Rami Fracture

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREOperative

surgical treatment

PROCEDURENonoperative

nonsurgical treatment

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Fracture of the pelvic ring * Fracture of the acetabulum

Exclusion criteria

* Patients unwilling to provide consent to participate.

Design outcomes

Primary

MeasureTime frameDescription
Return to work/activities0-24 months following injuryAverage time to return to work and activities

Secondary

MeasureTime frameDescription
Performance Measure- 10 meter walk test3, 6, 12 and 24 monthsParticipants 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.
Performance Measure- Five Time Sit to Stand Test3, 6, 12 and 24 monthsParticipants 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.
Complications0-24 months following injuryRates of readmission, reoperations and complications
Fracture Healing0-24 months following injuryUnion rates as measured clinically and radiographically. Xrays will be collected from the electronic medical record.
Performance Measure- Timed Up and Go Test3, 6, 12 and 24 monthsParticipants 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.
Change in patient-reported outcomes measurement information system (PROMIS 29) scoresbaseline, 3, 6, 12 and 24 monthsThe 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.

Countries

United States

Contacts

Primary ContactChristine Churchill, MA
Christine.Churchill@advocatehealth.org7043556947
Backup ContactErica Grochowski, MS
Erica.Grochowski@advocatehealth.org7043552000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026