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Acetabular FractureNCT07609758

Pediatric Acetabular Fracture Registry

An observational study of Acetabular Fracture, run by University of Utah at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
Acetabular Fracture
What is being tested?
Retrospective acetabular fracture and Prospective acetabular fracture
Type of treatment
Surgery or procedure
How many people
120 participants
Where
1 siteUnited States
Study dates
9 Apr 2025to Apr 2032
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 18 years
  • All sexes
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • University of Utah Orthopaedic Center

    Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: Pediatric Acetabular Fracture Registry: Long-Term Follow-Up and Outcomes

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.

Read more

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.

Read the detailed description

Introduction

This document is a protocol for a human research study. This two-phased study will be carried out in accordance with the applicable United States government regulations and the University of Utah and Primary Children's Hospital research policies and procedures. The first phase will consist of a retrospective cohort that will be contacted for follow-up data, while the second phase will consist of the creation of a prospective database.

Background and Current Clinical Data

Pelvic fractures, consisting of the pelvic ring and acetabulum, represent less than 0.2% of all pediatric fractures. Isolated acetabular fractures are estimated to represent 9.8% of pelvic fractures, while combined pelvic ring and acetabular fractures are estimated at 20%. Notably, these injuries occur as a result of high-energy trauma, most commonly during motor vehicle-related accidents.Despite the high-energy forces involved, pediatric patients are less likely to experience fracture-induced hemodynamic instability. This is due to factors such as limited displacement of fractures secondary to pelvis malleability, pelvic ligamentous strength, thickness of the pediatric periosteum and increased responsiveness of the pediatric hemostatic system. Consequently, the patient's life is more likely to be threatened by associated cranial, abdominal, thoracic, and neurological injuries, which occur in more than 60% of cases. Overall mortality rates are estimated between 3.2% to 18%. Acetabular fractures can also occur secondary to lower-energy mechanisms, such as hip dislocations during sports activity. The rarity of pediatric acetabulum fractures has resulted in limited high-quality data regarding clinical and patient reported outcomes (PRO), but the severity of these injuries indicates further observations are necessary.

The outcomes for pediatric acetabulum fractures are reported by a few small studies. Non- surgical and surgical management has resulted in acceptable clinical and radiographic outcomes. Past investigators have reported zero nonunions, one unplanned reoperation, and full return to activity in 18 patients. However, the study is limited by a small cohort and follow-up only to one year, which restricts the ability to observe the development of long-term complications such as arthritis or dysplasia. Other investigators have reported on 21 acetabulum fracture ORIF patients younger than 18 from 2001-2018, displaying favorable functional outcomes. However, only five patients had open physes, which severely limits the findings of the study to skeletally mature adolescents. Similar to adult acetabulum fractures, pediatric patients have a risk of post-traumatic osteoarthritis (PTOA). Additional complications of concern in skeletally immature patients are leg length inequality, hip dysplasia, and hip subluxation. These are secondary to a growth disturbance of the triradiate cartilage, which occurs due to osseous bridging across the cartilage or ossification of a physeal hematoma after injury. Growth disturbance has been reported in 14% of acetabulum fractures, while hip dysplasia has been estimated at 5%. However, the strength of both findings are limited by small sample sizes. Hip subluxation and dislocation are also associated with development of avascular necrosis (AVN) of the femoral head, osteonecrosis of the posterior acetabular wall, and sciatic nerve palsy. Hip reduction within 6 hours is associated with lower rates of AVN due to preservation of femoral head blood flow. While pediatric acetabulum fractures are associated with good outcomes, they are also associated with many potential complications that have lasting consequences for the patient. These outcomes will be best observed through long-term studies of the pediatric population.

There are few studies that report on the long-term PROs of pediatric acetabular fractures. Within the small subset of studies reporting PROs, there are a few tools used, such as the Merle d'Aubigne score, Short Musculoskeletal Functional Assessment, and 36-Item Short Form Survey. While each legacy measure provides specific, beneficial information relative to pelvic and acetabular injury, they are not standardized or widely used in other fracture patterns. The Patient Reported Outcomes Measurement Information System (PROMIS) is an internationally used measurement system developed by the National Institute of Health to produce a T-score standardized to the U.S. general population. PROMIS provides multiple benefits such as reducing patient burden using computer adaptive testing, integration into the electronic medical record, and validity across multiple populations. Using the Swedish Fracture Registry, investigators have identified and reported the PROMIS Scores of 63 pediatric pelvic fractures (31% response rate) at a mean follow-up of 3.5 years. Greater than 85% of respondents reported none or mild concerns in mobility, anxiety, depression, fatigue, peer relationships, pain interference and pain intensity, but PROMIS t-scores were never explicitly listed. Additionally, they failed to mention the number of patients with isolated or concomitant acetabular fractures who completed PROMIS surveys. The Hip Disability and Osteoarthritis Outcome Score (HOOS) is another validated and heavily used PRO, developed to assess the patients' opinion about hip pain related function and quality of life. HOOS has most commonly been used to capture outcomes related to hip osteoarthritis and total hip arthroplasty. To date, HOOS has not been used to describe pediatric acetabular fractures, but would allow for a hip specific assessment and comparison to patients with osteoarthritis. Accurate reporting of pediatric acetabular PROs is warranted, especially with minimal high-quality data on the topic.

Pediatric pelvic fractures are injuries carrying a high mortality and morbidity rate. Acetabulum fractures are a rare subset of pediatric injuries with limited high-quality research in fracture classification and treatment related clinical, radiographic, and patient reported outcomes. In adults, complex fracture patterns in polytraumatic or elderly patients are associated with complications, poor functioning and long-term prognosis. Past investigators reported that 21% of 816 operatively treated displaced acetabular fractures required conversion to THA within 20 years, however half of the conversions occurred within the first 1.5 years. In addition, investigators have reported a 100% three-year conversion rate to total hip arthroplasty (THA) as a result of PTOA if patients were over the age of 60, had femoral head damage, and acetabular impaction. Depending on fracture pattern, pediatric acetabulum fractures may carry a similar risk of PTOA and other complications such as AVN. They may also be associated with poor long-term PROs. This is troublesome for pediatric patients, who would have to live their productive adulthood with poor functioning and quality of life. There is significant progress to be made in identifying the prognosis of pediatric acetabular fractures and identifying factors related to poor outcomes.

Being tested
Retrospective acetabular fracture, Prospective acetabular fracture
Keywords
Pediatric, Acetabular Fracture, Registry, Long-Term Follow-Up, Outcomes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retrospective acetabular fractureProcedure or surgery

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

  • Prospective acetabular fractureProcedure or surgery

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

Study groups in NCT07609758
Study groupRoleWhat they receive
Group 1 - Retrospective acetabular fractureThe 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.
Receives: Procedure: Retrospective acetabular fracture
Group 2 - Prospective acetabular fractureThe 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.
Receives: Procedure: Prospective acetabular fracture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (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.

    Measured: Day 1 after consent into the study

  2. (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.

    Measured: 2-weeks, post-surgery

  3. (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.

    Measured: 6-weeks, post-surgery

  4. (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.

    Measured: 12-weeks, post-surgery

  5. (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.

    Measured: 1-year, post-surgery

  6. (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.

    Measured: 2-years, post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start9 Apr 2025
  3. Primary completionApr 2032 (estimated)
  4. Study completionApr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
120 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07609758
Sponsor's protocol ID
186147
Status last verified
May 2026
First submitted
8 May 2026
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acetabular Fracture, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(PROMIS) Physical Function (PF) questionnaire (time frame: Day 1 after consent into the study). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

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