NCT07609758

Brief Summary

The investigators primary objective is to determine the fracture patterns, displacement-based treatment decisions, immediate and long-term complications, clinical, radiographic and patient reported outcomes of acetabular fractures with open physes. Hypothesis: This study will demonstrate that more complex and displaced fracture patterns are associated with a greater incidence of complications and poorer outcomes. The investigators secondary objective is to create a pediatric acetabular registry that can be used to track fracture patterns, displacement-based treatment decisions, immediate and long-term complications, clinical, radiographic and patient reported outcomes of acetabular fractures with open physes. Hypothesis: This study will demonstrate that more complex and displaced fracture patterns are associated with a greater incidence of complications and poorer outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
69mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Apr 2025Apr 2032

Study Start

First participant enrolled

April 9, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2032

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

7 years

First QC Date

May 8, 2026

Last Update Submit

May 26, 2026

Conditions

Keywords

PediatricAcetabular FractureRegistryLong-Term Follow-UpOutcomes

Outcome Measures

Primary Outcomes (6)

  • (PROMIS) Physical Function (PF) questionnaire

    Retrospective acetabular fracture patients will be asked to answer a patient reported outcome questionnaire at a one-time clinic visit. The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.

    Day 1 after consent into the study

  • (PROMIS) Physical Function (PF) questionnaire

    Prospective acetabular fracture patients will receive questionnaires to collect objective patient reported outcomes. The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.

    2-weeks, post-surgery

  • (PROMIS) Physical Function (PF) questionnaire

    Prospective acetabular fracture patients will receive questionnaires to collect objective patient reported outcomes. The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.

    6-weeks, post-surgery

  • (PROMIS) Physical Function (PF) questionnaire

    Prospective acetabular fracture patients will receive questionnaires to collect objective patient reported outcomes. The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.

    12-weeks, post-surgery

  • (PROMIS) Physical Function (PF) questionnaire

    Prospective acetabular fracture patients will receive questionnaires to collect objective patient reported outcomes. The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.

    1-year, post-surgery

  • (PROMIS) Physical Function (PF) questionnaire

    Prospective acetabular fracture patients will receive questionnaires to collect objective patient reported outcomes. The PROMIS Physical Function T-score is a standardized score derived from a patient's responses. The T-score has a mean of 50 and a standard deviation of 10, based on a reference population (typically the U.S. general population or a specific clinical group). A T-score above 50 indicates better-than-average physical function. A T-score below 50 indicates below-average physical function.

    2-years, post-surgery

Study Arms (2)

Group 1 - Retrospective acetabular fracture

The investigators will recruit subjects meeting study criteria who received primary treatment of an acetabular fracture at the University of Utah and Primary Children's Hospital from 2000-present using the electronic data warehouse.

Procedure: Retrospective acetabular fracture

Group 2 - Prospective acetabular fracture

The investigators will recruit subjects from the University of Utah and Primary Children's Hospital Orthopedic Surgery department with a diagnosis of an acetabular fracture meeting inclusion/exclusion criteria.

Procedure: Prospective acetabular fracture

Interventions

Patients who received primary treatment of an acetabular fracture at the University of Utah and Primary Children's Hospital from 2000-present.

Group 1 - Retrospective acetabular fracture

Patients from the University of Utah and Primary Children's Hospital Orthopedic Surgery department with a diagnosis and surgery for an acetabular fracture.

Group 2 - Prospective acetabular fracture

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18 years or less (at time of injury) with open physes sustaining an acetabular fracture with primary treatment occurring at either University of Utah Hospital or Primary Children's Hospital from 2000-present.

You may qualify if:

  • Patients aged 18 years or less (at time of injury) with open physes sustaining an acetabular fracture with primary treatment occurring at either University of Utah Hospital or Primary Children's Hospital from 2000-present.
  • Informed consent can be obtained from parent, guardian, or family member.

You may not qualify if:

  • History of metabolic or genetic bone disease (Ricket's, Osteogenesis Imperfecta),
  • pathologic fracture,
  • non-ambulatory prior to injury, paraplegic,
  • hemiplegic, or cognitive impairment that inhibits the participant's ability to answer patient reported outcome surveys.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Orthopaedic Center

Salt Lake City, Utah, 84108, United States

Location

Study Officials

  • David Rothberg, M.D.

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 27, 2026

Study Start

April 9, 2025

Primary Completion (Estimated)

April 1, 2032

Study Completion (Estimated)

April 1, 2032

Last Updated

May 27, 2026

Record last verified: 2026-05

Locations