Clinical trial NCT04615104: Pelvic and Acetabular Fracture: A Prospective Observational Study
Official title: Functional, Clinical, and Performance Outcomes Following Pelvic and Acetabular Fracture: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Fracture
Acetabular Fracture
Pubic Rami Fracture
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated for pelvic or acetabular fracture at an orthopaedic trauma practices.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Fracture of the pelvic ring
* Fracture of the acetabulum

Exclusion Criteria:

* Patients unwilling to provide consent to participate.

Primary outcomes:
measure: Return to work/activities
timeFrame: 0-24 months following injury
Secondary outcomes:
measure: Change in patient-reported outcomes measurement information system (PROMIS 29) scores
timeFrame: baseline, 3, 6, 12 and 24 months
measure: Fracture Healing
timeFrame: 0-24 months following injury
measure: Complications
timeFrame: 0-24 months following injury
measure: Performance Measure- 10 meter walk test
timeFrame: 3, 6, 12 and 24 months
measure: Performance Measure- Five Time Sit to Stand Test
timeFrame: 3, 6, 12 and 24 months
measure: Performance Measure- Timed Up and Go Test
timeFrame: 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health- Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Madhav Karunakar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Rachel Seymour, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Pohlemann T, Gansslen A, Schellwald O, Culemann U, Tscherne H. Outcome after pelvic ring injuries. Injury. 1996;27 Suppl 2:B31-8.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.