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NCT Number: NCT04615104

Pelvic and Acetabular Fracture: A Prospective Observational Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atrium Health- Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location status: Recruiting

Location contact

Christine Churchill, MA

CONTACT

[email protected]

704-355-6947

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fracture of the pelvic ring
  • Fracture of the acetabulum

Exclusion criteria

  • Patients unwilling to provide consent to participate.

Treatment and study plan

Operative

Procedure

surgical treatment

Nonoperative

Procedure

nonsurgical treatment

Primary outcomes

  1. Return to work/activities

    Time frame: 0-24 months following injury

    Average time to return to work and activities

Secondary outcomes

  1. Change in patient-reported outcomes measurement information system (PROMIS 29) scores

    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.

  2. Fracture Healing

    Time frame: 0-24 months following injury

    Union rates as measured clinically and radiographically. Xrays will be collected from the electronic medical record.

  3. Complications

    Time frame: 0-24 months following injury

    Rates of readmission, reoperations and complications

  4. Performance Measure- 10 meter walk test

    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.

  5. Performance Measure- Five Time Sit to Stand Test

    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.

  6. Performance Measure- Timed Up and Go Test

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Churchill, MA

CONTACT

[email protected]

7043556947

Erica Grochowski, MS

CONTACT

[email protected]

7043552000

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: PACE

Important dates

Study start
2020
Primary completion
2027
Study completion
2029
First posted
Nov 4, 2020
Registry last updated
Nov 21, 2025

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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