Comparison of INFIX and Plating for Pelvic Ring Injuries With Symphysis Disruptions

Anterior Pelvic Ring Injury With Symphysis Disruption Clinical Trial

Official title:

Prospective Randomized Comparison of Subcutaneous Internal Fixation ("INFIX") and Plating for Pelvic Ring Injuries With Symphysis Disruptions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02399319
• Other study ID #: 1403899155
• Status: Terminated
• Phase: N/A
• First received: March 23, 2015
• Last updated: January 22, 2018
• Start date: October 2014
• Est. completion date: July 21, 2016

Study information

• Verified date: July 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare subcutaneous internal fixation and open plating of the symphysis in patients with a disruption of the symphysis requiring stabilization.

Description:

The aim of this study is to determine whether either one of the two procedures has significant advantages over the other. The null hypothesis of this study is that there is no difference between plating and subcutaneous internal fixation of symphysis disruptions with respect to primary and secondary outcomes. The study is a randomized trial with patients who sustained a symphysis disruption who will randomize to either closed reduction and subcutaneous internal fixation, or open reduction and plating of the symphysis. There will also be two observational arms of the study, patients who do not agree to randomization and will receive internal fixation according to the treating surgeon's discretion and patients with a symphysis disruption that do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion. Clinical assessments will occur at the time of hospital admission and at all post-operative follow-up intervals (2 weeks, 6 weeks, 3 months, 6months, 12 months, and 24 months).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 21, 2016
• Est. primary completion date: July 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A symphysis disruption either in the coronal and/or sagittal plane on anterior-posterior , inlet and/or outlet pelvic radiographs

• Need for anterior pelvic ring stabilization

• Injury amenable to plating as well as subcutaneous internal fixation per the treating surgeon's opinion

• Patient was ambulatory prior to sustaining the injury

• Provision of informed consent by patient or proxy

Exclusion Criteria:

• Patients with a slim build with little subcutaneous fat who cannot be treated with a subcutaneous internal fixator based on the treating surgeon's opinion

• Patients who are deemed not likely to follow-up (e.g. patients who live more than 50 miles away and patients with no fixed address)

• Moderately or severely cognitively impaired patients

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Anterior Pelvic Ring Injury With Symphysis Disruption
• Wounds and Injuries

Intervention

Procedure:
• Internal Fixator
Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally.
• Symphyseal Plate
A plate that spans across the symphysis to maintain reduction and stability.

Locations

Country	Name	City	State
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (32)

Cole PA, Gauger EM, Anavian J, Ly TV, Morgan RA, Heddings AA. Anterior pelvic external fixator versus subcutaneous internal fixator in the treatment of anterior ring pelvic fractures. J Orthop Trauma. 2012 May;26(5):269-77. doi: 10.1097/BOT.0b013e3182410577. — View Citation

Dalal SA, Burgess AR, Siegel JH, Young JW, Brumback RJ, Poka A, Dunham CM, Gens D, Bathon H. Pelvic fracture in multiple trauma: classification by mechanism is key to pattern of organ injury, resuscitative requirements, and outcome. J Trauma. 1989 Jul;29(7):981-1000; discussion 1000-2. — View Citation

Drummond M. Introducing economic and quality of life measurements into clinical studies. Ann Med. 2001 Jul;33(5):344-9. Review. — View Citation

Gardner MJ, Mehta S, Mirza A, Ricci WM. Anterior pelvic reduction and fixation using a subcutaneous internal fixator. J Orthop Trauma. 2012 May;26(5):314-21. doi: 10.1097/BOT.0b013e318220bb22. — View Citation

Holstein JH, Pizanis A, Köhler D, Pohlemann T; Working Group Quality of Life After Pelvic Fractures. What are predictors for patients' quality of life after pelvic ring fractures? Clin Orthop Relat Res. 2013 Sep;471(9):2841-5. doi: 10.1007/s11999-013-2840-y. — View Citation

Kabak S, Halici M, Tuncel M, Avsarogullari L, Baktir A, Basturk M. Functional outcome of open reduction and internal fixation for completely unstable pelvic ring fractures (type C): a report of 40 cases. J Orthop Trauma. 2003 Sep;17(8):555-62. — View Citation

Lefaivre KA, Slobogean GP, Ngai JT, Broekhuyse HM, O'Brien PJ. What outcomes are important for patients after pelvic trauma? Subjective responses and psychometric analysis of three published pelvic-specific outcome instruments. J Orthop Trauma. 2014 Jan;28(1):23-7. doi: 10.1097/BOT.0b013e3182945fe9. — 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: 10.1302/0301-620X.94B4.27960. Review. — View Citation

Majeed SA. External fixation of the injured pelvis. The functional outcome. J Bone Joint Surg Br. 1990 Jul;72(4):612-4. — View Citation

Majeed SA. Grading the outcome of pelvic fractures. J Bone Joint Surg Br. 1989 Mar;71(2):304-6. — View Citation

Matta JM, Saucedo T. Internal fixation of pelvic ring fractures. Clin Orthop Relat Res. 1989 May;(242):83-97. — View Citation

Matta JM. Indications for anterior fixation of pelvic fractures. Clin Orthop Relat Res. 1996 Aug;(329):88-96. — View Citation

McCarthy ML, MacKenzie EJ, Bosse MJ, Copeland CE, Hash CS, Burgess AR. Functional status following orthopedic trauma in young women. J Trauma. 1995 Nov;39(5):828-36; discussion 836-7. — View Citation

Merriman DJ, Ricci WM, McAndrew CM, Gardner MJ. Is application of an internal anterior pelvic fixator anatomically feasible? Clin Orthop Relat Res. 2012 Aug;470(8):2111-5. doi: 10.1007/s11999-012-2287-6. — View Citation

Moazzam C, Heddings AA, Moodie P, Cole PA. Anterior pelvic subcutaneous internal fixator application: an anatomic study. J Orthop Trauma. 2012 May;26(5):263-8. doi: 10.1097/BOT.0b013e31823e6b82. — 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):293-8. doi: 10.1097/BOT.0b013e31816b6b4e. — 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. — View Citation

PELTIER LF. COMPLICATIONS ASSOCIATED WITH FRACTURES OF THE PELVIS. J Bone Joint Surg Am. 1965 Jul;47:1060-9. — View Citation

Pohlemann T, Bosch U, Gänsslen A, Tscherne H. The Hannover experience in management of pelvic fractures. Clin Orthop Relat Res. 1994 Aug;(305):69-80. — View Citation

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

Raman R, Roberts CS, Pape HC, Giannoudis PV. Implant retention and removal after internal fixation of the symphysis pubis. Injury. 2005 Jul;36(7):827-31. Epub 2005 Feb 25. Review. — View Citation

Scaglione M, Parchi P, Digrandi G, Latessa M, Guido G. External fixation in pelvic fractures. Musculoskelet Surg. 2010 Nov;94(2):63-70. doi: 10.1007/s12306-010-0084-5. Epub 2010 Nov 18. — View Citation

Sprague S, Leece P, Bhandari M, Tornetta P 3rd, Schemitsch E, Swiontkowski MF; S.P.R.I.N.T. Investigators. Limiting loss to follow-up in a multicenter randomized trial in orthopedic surgery. Control Clin Trials. 2003 Dec;24(6):719-25. — 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. — View Citation

Tornetta P 3rd, Dickson K, Matta JM. Outcome of rotationally unstable pelvic ring injuries treated operatively. Clin Orthop Relat Res. 1996 Aug;(329):147-51. — 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. — View Citation

Vaidya R, Colen R, Vigdorchik J, Tonnos F, Sethi A. Treatment of unstable pelvic ring injuries with an internal anterior fixator and posterior fixation: initial clinical series. J Orthop Trauma. 2012 Jan;26(1):1-8. doi: 10.1097/BOT.0b013e318233b8a7. — View Citation

Vaidya R, Kubiak EN, Bergin PF, Dombroski DG, Critchlow RJ, Sethi A, Starr AJ. Complications of anterior subcutaneous internal fixation for unstable pelvis fractures: a multicenter study. Clin Orthop Relat Res. 2012 Aug;470(8):2124-31. doi: 10.1007/s11999-011-2233-z. — View Citation

Vallier HA, Cureton BA, Schubeck D, Wang XF. Functional outcomes in women after high-energy pelvic ring injury. J Orthop Trauma. 2012 May;26(5):296-301. doi: 10.1097/BOT.0b013e318221e94e. — 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

Vallier HA, Cureton BA, Schubeck D. Pregnancy outcomes after pelvic ring injury. J Orthop Trauma. 2012 May;26(5):302-7. doi: 10.1097/BOT.0b013e31822428c5. — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Outcomes	The primary objective is to compare functional outcomes between subcutaneous internal fixation and symphyseal plating as measured by the PROMIS v1.2-Physical Function instrument.	24 hours - 24 months
Secondary	Compare the health-related quality of life and functional outcome scores	We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: PROMIS v1.1 - Pain Interference, PROMIS v1.2 - Mobility, PROMIS v1.0 - Global Satisfaction with Sex Life, PROMIS v1.0 - Depression, Majeed score, SF-12, VAS, patient satisfaction score, time to return to work, revision surgery, use of assistive walking devices, length of hospital stay, and for me, PROMIS v1.0 - Erectile Function.	24 hours - 24 months

External Links

•   PROMIS outcome questionnaires