NCT04615104

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress64%
Jan 2020Dec 2029

Study Start

First participant enrolled

January 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

7.9 years

First QC Date

October 29, 2020

Last Update Submit

November 20, 2025

Conditions

Pelvic FractureAcetabular FracturePubic Rami Fracture

Outcome Measures

Primary Outcomes (1)

  • Return to work/activities

    Average time to return to work and activities

    0-24 months following injury

Secondary Outcomes (6)

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

    baseline, 3, 6, 12 and 24 months

  • Fracture Healing

    0-24 months following injury

  • Complications

    0-24 months following injury

  • Performance Measure- 10 meter walk test

    3, 6, 12 and 24 months

  • Performance Measure- Five Time Sit to Stand Test

    3, 6, 12 and 24 months

  • +1 more secondary outcomes

Study Arms (2)

Pelvic Ring Fracture

Patients with pelvic ring fractures.

Procedure: OperativeProcedure: Nonoperative

Acetabular Fracture

Patients with acetabular fractures.

Procedure: OperativeProcedure: Nonoperative

Interventions

OperativePROCEDURE

surgical treatment

Acetabular FracturePelvic Ring Fracture
NonoperativePROCEDURE

nonsurgical treatment

Acetabular FracturePelvic Ring Fracture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated for pelvic or acetabular fracture at an orthopaedic trauma practices.

You may qualify if:

  • Fracture of the pelvic ring
  • Fracture of the acetabulum

You may not qualify if:

  • Patients unwilling to provide consent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health- Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

Related Publications (21)

  • 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: 12113532RESULT

  • 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: 17092504RESULT

  • 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: 24360668RESULT

  • 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: 22011632RESULT

  • 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: 17693842RESULT

  • 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: 19571085RESULT

  • 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: 8769433RESULT

  • 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: 18090021RESULT

  • Tornetta P 3rd, Matta JM. Outcome of operatively treated unstable posterior pelvic ring disruptions. Clin Orthop Relat Res. 1996 Aug;(329):186-93. doi: 10.1097/00003086-199608000-00022.

    PMID: 8769450RESULT

  • Pohlemann T, Gansslen A, Schellwald O, Culemann U, Tscherne H. Outcome after pelvic ring injuries. Injury. 1996;27 Suppl 2:B31-8.

    PMID: 8915200RESULT

  • Cole JD, Blum DA, Ansel LJ. Outcome after fixation of unstable posterior pelvic ring injuries. Clin Orthop Relat Res. 1996 Aug;(329):160-79. doi: 10.1097/00003086-199608000-00020.

    PMID: 8769448RESULT

  • Brenneman FD, Katyal D, Boulanger BR, Tile M, Redelmeier DA. Long-term outcomes in open pelvic fractures. J Trauma. 1997 May;42(5):773-7. doi: 10.1097/00005373-199705000-00003.

    PMID: 9191654RESULT

  • Mullis BH, Sagi HC. Minimum 1-year follow-up for patients with vertical shear sacroiliac joint dislocations treated with iliosacral screws: does joint ankylosis or anatomic reduction contribute to functional outcome? J Orthop Trauma. 2008 May-Jun;22(5):293-8. doi: 10.1097/BOT.0b013e31816b6b4e.

    PMID: 18448980RESULT

  • Nepola JV, Trenhaile SW, Miranda MA, Butterfield SL, Fredericks DC, Riemer BL. Vertical shear injuries: is there a relationship between residual displacement and functional outcome? J Trauma. 1999 Jun;46(6):1024-9; discussion 1029-30. doi: 10.1097/00005373-199906000-00007.

    PMID: 10372618RESULT

  • Dujardin FH, Hossenbaccus M, Duparc F, Biga N, Thomine JM. Long-term functional prognosis of posterior injuries in high-energy pelvic disruption. J Orthop Trauma. 1998 Mar-Apr;12(3):145-50; discussion 150-1. doi: 10.1097/00005131-199803000-00001.

    PMID: 9553853RESULT

  • Hoffmann MF, Jones CB, Sietsema DL. Persistent impairment after surgically treated lateral compression pelvic injury. Clin Orthop Relat Res. 2012 Aug;470(8):2161-72. doi: 10.1007/s11999-012-2247-1.

    PMID: 22278851RESULT

  • Lefaivre KA, Slobogean G, Starr AJ, Guy P, O'brien PJ, Macadam SA. Methodology and interpretation of radiographic outcomes in surgically treated pelvic fractures: a systematic review. J Orthop Trauma. 2012 Aug;26(8):474-81. doi: 10.1097/BOT.0b013e3182323aa2.

    PMID: 22391403RESULT

  • Borg T, Berg P, Fugl-Meyer K, Larsson S. Health-related quality of life and life satisfaction in patients following surgically treated pelvic ring fractures. A prospective observational study with two years follow-up. Injury. 2010 Apr;41(4):400-4. doi: 10.1016/j.injury.2009.11.006. Epub 2009 Dec 14.

    PMID: 20005513RESULT

  • Oliver CW, Twaddle B, Agel J, Routt ML Jr. Outcome after pelvic ring fractures: evaluation using the medical outcomes short form SF-36. Injury. 1996 Nov;27(9):635-41. doi: 10.1016/s0020-1383(96)00100-3.

    PMID: 9039360RESULT

  • Papakostidis C, Kanakaris NK, Kontakis G, Giannoudis PV. Pelvic ring disruptions: treatment modalities and analysis of outcomes. Int Orthop. 2009 Apr;33(2):329-38. doi: 10.1007/s00264-008-0555-6. Epub 2008 May 7.

    PMID: 18461325RESULT

  • Lefaivre KA, Slobogean GP, Valeriote J, O'Brien PJ, Macadam SA. Reporting and interpretation of the functional outcomes after the surgical treatment of disruptions of the pelvic ring: a systematic review. J Bone Joint Surg Br. 2012 Apr;94(4):549-55. doi: 10.1302/0301-620X.94B4.27960.

    PMID: 22434474RESULT

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Madhav Karunakar, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

  • Rachel Seymour, PhD

    Wake Forest University Health Sciences

    STUDY DIRECTOR

Central Study Contacts

Christine Churchill, MA

CONTACT

7043556947Christine.Churchill@advocatehealth.org

Erica Grochowski, MS

CONTACT

7043552000Erica.Grochowski@advocatehealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

January 1, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2029

Last Updated

November 21, 2025

Record last verified: 2025-11

Locations

US(1)