Acetabular Fracture Clinical Trial
— PACEOfficial title:
Functional, Clinical, and Performance Outcomes Following Pelvic and Acetabular Fracture: A Prospective Observational Study
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2028 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Fracture of the pelvic ring - Fracture of the acetabulum Exclusion Criteria: - Patients unwilling to provide consent to participate. |
Country | Name | City | State |
---|---|---|---|
United States | Atrium Health- Carolinas Medical Center | Charlotte | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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 — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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.0b013e3182323a — View 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: — View 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. — View 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):29 — View 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: 10.1097/0000537 — View 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. — View 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. — View Citation
Pohlemann T, Gansslen A, Schellwald O, Culemann U, Tscherne H. Outcome after pelvic ring injuries. Injury. 1996;27 Suppl 2:B31-8. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Return to work/activities | Average time to return to work and activities | 0-24 months following injury | |
Secondary | Change in patient-reported outcomes measurement information system (PROMIS 29) scores | The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome. | baseline, 3, 6, 12 and 24 months | |
Secondary | Fracture Healing | Union rates as measured clinically and radiographically. Xrays will be collected from the electronic medical record. | 0-24 months following injury | |
Secondary | Complications | Rates of readmission, reoperations and complications | 0-24 months following injury | |
Secondary | Performance Measure- 10 meter walk test | Participants complete a modified 10 meter walk test which involves the subject starting from a standing position, walking 5 meters at a comfortable pace, turning around, and then walking back 5 meters to the original starting point. The test is repeated twice for each subject. | 3, 6, 12 and 24 months | |
Secondary | Performance Measure- Five Time Sit to Stand Test | Participants begin from a seated position and are directed to come to a full standing position without push off assistance from upper extremities and then return to a seated position without upper extremity assist. | 3, 6, 12 and 24 months | |
Secondary | Performance Measure- Timed Up and Go Test | Participants begin in a seated position. They are directed to stand and walk 3 meters to a cone on the floor. They are to round the cone in a continuous motion, walk back to the chair, turn again and be seated. The entire test is performed at a comfortable and safe speed for the patient. | 3, 6, 12 and 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03478189 -
The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction
|
||
Completed |
NCT04660734 -
Advantages of 3D Printing in the Management of Acetabular Fractures
|
N/A | |
Not yet recruiting |
NCT04073329 -
Acetabular Fracture Reduction Assessment
|
||
Completed |
NCT01839565 -
Quadrilateral Surface Plate (QSP) Focused Registry
|
||
Not yet recruiting |
NCT04393571 -
The Utility of Mobile Based Patient Reported Outcome Measures in Patients With Acetabular Fractures: A Randomized Controlled Trial.
|
N/A | |
Recruiting |
NCT06005753 -
Surgical Treatment of Injuries and Consequences of the Acetabulum
|
N/A | |
Recruiting |
NCT05606042 -
Curvafix® Intramedullary System for Fixation of Pelvic and Acetabular Fractures, A Post Market Evaluation
|
||
Enrolling by invitation |
NCT04867278 -
Heterotopic Ossification Prophylaxis
|
N/A | |
Completed |
NCT03305640 -
Identification of an Atypical acetabuLar frActure With an Independent Roof Component: Incidence and Description
|
N/A | |
Completed |
NCT03316235 -
New, Easy and Efficient Ways to CLassify AcetabulaR Fractures
|
N/A | |
Not yet recruiting |
NCT04724811 -
Weight-bearing of Surgically Treated Acetabular Fractures.
|
N/A | |
Completed |
NCT03929536 -
Treatment of Acetabular Fractures in Elderly Patients
|
||
Not yet recruiting |
NCT03713853 -
Geriatric Acetabular fracTures: Open Reduction Internal Fixation Versus Replacement
|
||
Completed |
NCT03152266 -
Function Outcome of Impaction Injuries in Acetabular Fractures
|
||
Completed |
NCT04902209 -
Static Balance Disorders in Patients After Surgical Treatment of Hip Acetabular Fractures
|
||
Completed |
NCT04303442 -
Corona Mortis in Patients Undergoing TEP for Inguinal Hernia
|
||
Withdrawn |
NCT06238804 -
Characteristic Analysis and Surgical Exploration for Acetabular Roof Fractures: Multicenter Retrospective Cohort Study
|
||
Completed |
NCT02892240 -
Retrospective Evaluation of Total Hip Replacement After Acetabular Fractures
|
||
Completed |
NCT04626388 -
Postoperative Score Predictive of the Prognosis of Acetabular Fractures
|
||
Completed |
NCT03952026 -
Impact of Associated Abdominal Injuries on Clinical and Operative Outcome in Pelvic Injuries
|