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Recruiting NCT04615104

Pelvic and Acetabular Fracture: A Prospective Observational Study

— Observational Pelvic Fracture Acetabular Fracture Pubic Rami Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Operative, Nonoperative.
Who it may be relevant to
Registry conditions: Pelvic Fracture, Acetabular Fracture, Pubic Rami Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Procedure Operative
    surgical treatment
  • Procedure Nonoperative
    nonsurgical treatment

Primary outcome measures

  • Return to work/activities [Time frame: 0-24 months following injury]
Secondary outcome measures (6)
  • Change in patient-reported outcomes measurement information system (PROMIS 29) scores [Time frame: baseline, 3, 6, 12 and 24 months]
  • Fracture Healing [Time frame: 0-24 months following injury]
  • Complications [Time frame: 0-24 months following injury]
  • Performance Measure- 10 meter walk test [Time frame: 3, 6, 12 and 24 months]
  • Performance Measure- Five Time Sit to Stand Test [Time frame: 3, 6, 12 and 24 months]
  • Performance Measure- Timed Up and Go Test [Time frame: 3, 6, 12 and 24 months]

Eligibility criteria

Inclusion criteria

  • Fracture of the pelvic ring
  • Fracture of the acetabulum

Exclusion criteria

  • Patients unwilling to provide consent to participate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Atrium Health- Carolinas Medical Center — Charlotte

Publications

  • Demetriades D, Karaiskakis M, Toutouzas K, Alo K, Velmahos G, Chan L. Pelvic fractures: epidemiology and predictors of associated abdominal injuries and outcomes. J Am Coll Surg. 2002 Jul;195(1):1-10. doi: 10.1016/s1072-7515(02)01197-3. PMID 12113532
  • Katsoulis E, Giannoudis PV. Impact of timing of pelvic fixation on functional outcome. Injury. 2006 Dec;37(12):1133-42. doi: 10.1016/j.injury.2006.07.017. Epub 2006 Nov 7. PMID 17092504
  • Wong JM, Bucknill A. Fractures of the pelvic ring. Injury. 2017 Apr;48(4):795-802. doi: 10.1016/j.injury.2013.11.021. Epub 2013 Dec 2. PMID 24360668
  • Vallier HA, Cureton BA, Schubeck D. Pelvic ring injury is associated with sexual dysfunction in women. J Orthop Trauma. 2012 May;26(5):308-13. doi: 10.1097/BOT.0b013e31821d700e. PMID 22011632
  • Metze M, Tiemann AH, Josten C. Male sexual dysfunction after pelvic fracture. J Trauma. 2007 Aug;63(2):394-401. doi: 10.1097/01.ta.0000241145.02748.df. PMID 17693842
  • Collinge CA, Archdeacon MT, LeBus G. Saddle-horn injury of the pelvis. The injury, its outcomes, and associated male sexual dysfunction. J Bone Joint Surg Am. 2009 Jul;91(7):1630-6. doi: 10.2106/JBJS.H.00477. PMID 19571085
  • Reilly MC, Zinar DM, Matta JM. Neurologic injuries in pelvic ring fractures. Clin Orthop Relat Res. 1996 Aug;(329):28-36. doi: 10.1097/00003086-199608000-00005. PMID 8769433
  • Suzuki T, Shindo M, Soma K, Minehara H, Nakamura K, Uchino M, Itoman M. Long-term functional outcome after unstable pelvic ring fracture. J Trauma. 2007 Oct;63(4):884-8. doi: 10.1097/01.ta.0000235888.90489.fc. PMID 18090021

Identifiers

NCT: NCT04615104 · IRB00082574 · 10-19-18E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗