Pelvic and Acetabular Fracture: A Prospective Observational Study

NCT ID: NCT04615104

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pelvic Fracture Acetabular Fracture Pubic Rami Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pelvic Ring Fracture

Patients with pelvic ring fractures.

Operative

Intervention Type PROCEDURE

surgical treatment

Nonoperative

Intervention Type PROCEDURE

nonsurgical treatment

Acetabular Fracture

Patients with acetabular fractures.

Operative

Intervention Type PROCEDURE

surgical treatment

Nonoperative

Intervention Type PROCEDURE

nonsurgical treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Operative

surgical treatment

Intervention Type PROCEDURE

Nonoperative

nonsurgical treatment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fracture of the pelvic ring
* Fracture of the acetabulum

Exclusion Criteria

* Patients unwilling to provide consent to participate.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Madhav Karunakar, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Rachel Seymour, PhD

Role: STUDY_DIRECTOR

Wake Forest University Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Atrium Health- Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christine Churchill, MA

Role: CONTACT

Phone: 7043556947

Email: [email protected]

Erica Grochowski, MS

Role: CONTACT

Phone: 7043552000

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christine Churchill, MA

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 12113532 (View on PubMed)

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.

Reference Type RESULT
PMID: 17092504 (View on PubMed)

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.

Reference Type RESULT
PMID: 24360668 (View on PubMed)

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.

Reference Type RESULT
PMID: 22011632 (View on PubMed)

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.

Reference Type RESULT
PMID: 17693842 (View on PubMed)

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.

Reference Type RESULT
PMID: 19571085 (View on PubMed)

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.

Reference Type RESULT
PMID: 8769433 (View on PubMed)

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.

Reference Type RESULT
PMID: 18090021 (View on PubMed)

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.

Reference Type RESULT
PMID: 8769450 (View on PubMed)

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

Reference Type RESULT
PMID: 8915200 (View on PubMed)

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.

Reference Type RESULT
PMID: 8769448 (View on PubMed)

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.

Reference Type RESULT
PMID: 9191654 (View on PubMed)

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.

Reference Type RESULT
PMID: 18448980 (View on PubMed)

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.

Reference Type RESULT
PMID: 10372618 (View on PubMed)

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.

Reference Type RESULT
PMID: 9553853 (View on PubMed)

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.

Reference Type RESULT
PMID: 22278851 (View on PubMed)

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.

Reference Type RESULT
PMID: 22391403 (View on PubMed)

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.

Reference Type RESULT
PMID: 20005513 (View on PubMed)

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.

Reference Type RESULT
PMID: 9039360 (View on PubMed)

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.

Reference Type RESULT
PMID: 18461325 (View on PubMed)

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.

Reference Type RESULT
PMID: 22434474 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10-19-18E

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00082574

Identifier Type: -

Identifier Source: org_study_id