Comparison of Subcutaneous INFIX and EXFIX for Anterior Pelvic Ring Fractures Requiring Stabilization

NCT02403154 | Terminated Results DMC

• 1 other identifier: 1404651343
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to compare patient outcomes of two treatment methods that are currently used as standard of care to treat anterior pelvic ring injuries that require stabilization. The two treatment methods are subcutaneous internal fixation (INFIX) and external fixation (EXFIX). Patients will be given the opportunity to opt out of randomization and participate in one of the observational arms. The first observational arm is comprised of those patients who do not want to randomize and they will undergo anterior pelvic ring stabilization according to the treating surgeon's discretion. The second observational arm will be comprised of patients who consent to be in the study but whose pelvic ring fractures do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion.

Conditions

Anterior Pelvic Ring Fractures

Keywords

Anterior pelvic ring; Internal fixation; External fixation; Orthopaedic; Orthopedic; pubic rami

Outcome Measures

Primary Outcomes (1)

• Functional Outcomes (PROMIS v1.2-Physical Function Instrument)

  The primary objective is to compare functional outcomes between subcutaneous internal fixation and external fixation as measured by the PROMIS v1.2-Physical Function instrument.

  24 hrs - 24 months

Secondary Outcomes (6)

• Implant Breakage or Failure Rates

  24 hours - 24 months

• Infection Rates

  24 hours - 24 months

• Revision Surgery Rates

  24 hours - 24 months

• Health-related Qualify of Life

  24 hours - 24 months

• Predictors of Outcome (Factors Such as Age, Gender, BMI, Additional Injuries)

  24 hours - 24 months

Study Arms (4)

Randomized to Internal Fixator

EXPERIMENTAL

Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.

Procedure: Internal Fixator

Randomized to External Fixator

EXPERIMENTAL

Patient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.

Procedure: External fixator

Observational - Internal Fixator

OTHER

Patient signed consent but did not want to randomize their procedure and either the treating physician selected the internal fixator intervention based on their preference for the specific case or the patient chose the internal fixator.

Procedure: Internal Fixator

Observational - External Fixator

OTHER

Patient signed consent but did not want to randomize their procedure and either the treating physician selected the external fixator intervention based on their preference for the specific case or the patient chose the external fixator.

Procedure: External fixator

Interventions

Internal Fixator PROCEDURE

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.

Observational - Internal Fixator; Randomized to Internal Fixator

External fixator PROCEDURE

External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body.

Observational - External Fixator; Randomized to External Fixator

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• One or more fractures of the anterior pelvic ring (pubic rami)
• Need for anterior pelvic ring stabilization
• Injury amenable to external 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (31)

• Arazi M, Kutlu A, Mutlu M, Yel M, Kapiciglu MI. The pelvic external fixation: the mid-term results of 41 patients treated with a newly designed fixator. Arch Orthop Trauma Surg. 2000;120(10):584-6. doi: 10.1007/s004020000142.

  PMID: 11110141 BACKGROUND

• Gansslen A, Pohlemann T, Krettek C. [A simple supraacetabular external fixation for pelvic ring fractures]. Oper Orthop Traumatol. 2005 Sep;17(3):296-312. doi: 10.1007/s00064-005-1134-2. German.

  PMID: 16132252 BACKGROUND

• Hupel TM, McKee MD, Waddell JP, Schemitsch EH. Primary external fixation of rotationally unstable pelvic fractures in obese patients. J Trauma. 1998 Jul;45(1):111-5. doi: 10.1097/00005373-199807000-00024.

  PMID: 9680022 BACKGROUND

• Lindahl J, Hirvensalo E, Bostman O, Santavirta S. Failure of reduction with an external fixator in the management of injuries of the pelvic ring. Long-term evaluation of 110 patients. J Bone Joint Surg Br. 1999 Nov;81(6):955-62. doi: 10.1302/0301-620x.81b6.8571.

  PMID: 10615965 BACKGROUND

• Majeed SA. External fixation of the injured pelvis. The functional outcome. J Bone Joint Surg Br. 1990 Jul;72(4):612-4. doi: 10.1302/0301-620X.72B4.2380212.

  PMID: 2380212 BACKGROUND

• Mears DC, Fu FH. Modern concepts of external skeletal fixation of the pelvis. Clin Orthop Relat Res. 1980 Sep;(151):65-72.

  PMID: 7418325 BACKGROUND

• Tucker MC, Nork SE, Simonian PT, Routt ML Jr. Simple anterior pelvic external fixation. J Trauma. 2000 Dec;49(6):989-94. doi: 10.1097/00005373-200012000-00002.

  PMID: 11130512 BACKGROUND

• Majeed SA. Grading the outcome of pelvic fractures. J Bone Joint Surg Br. 1989 Mar;71(2):304-6. doi: 10.1302/0301-620X.71B2.2925751.

  PMID: 2925751 BACKGROUND

• Riemer BL, Butterfield SL, Diamond DL, Young JC, Raves JJ, Cottington E, Kislan K. Acute mortality associated with injuries to the pelvic ring: the role of early patient mobilization and external fixation. J Trauma. 1993 Nov;35(5):671-5; discussion 676-7. doi: 10.1097/00005373-199311000-00003.

  PMID: 8230327 BACKGROUND

• Wild JJ Jr, Hanson GW, Tullos HS. Unstable fractures of the pelvis treated by external fixation. J Bone Joint Surg Am. 1982 Sep;64(7):1010-20.

  PMID: 7118964 BACKGROUND

• 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.

  PMID: 22357081 BACKGROUND

• 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.

  PMID: 22048189 BACKGROUND

• 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.

  PMID: 22383020 BACKGROUND

• 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.

  PMID: 22337488 BACKGROUND

• 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.

  PMID: 22048183 BACKGROUND

• 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.

  PMID: 22219004 BACKGROUND

• Drummond M. Introducing economic and quality of life measurements into clinical studies. Ann Med. 2001 Jul;33(5):344-9. doi: 10.3109/07853890109002088.

  PMID: 11491193 BACKGROUND

• 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. doi: 10.1097/00005650-199603000-00003.

  PMID: 8628042 BACKGROUND

• PELTIER LF. COMPLICATIONS ASSOCIATED WITH FRACTURES OF THE PELVIS. J Bone Joint Surg Am. 1965 Jul;47:1060-9. No abstract available.

  PMID: 14318624 BACKGROUND

• 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.

  PMID: 21086087 BACKGROUND

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

  PMID: 8050249 BACKGROUND

• Holstein JH, Pizanis A, Kohler 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.

  PMID: 23408176 BACKGROUND

• 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. doi: 10.1097/00005131-200309000-00003.

  PMID: 14504576 BACKGROUND

• 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. doi: 10.1097/00005373-199511000-00005.

  PMID: 7473997 BACKGROUND

• 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: 18448980 BACKGROUND

• 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: 9039360 BACKGROUND

• 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: 18090021 BACKGROUND

• 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.

  PMID: 22337480 BACKGROUND

• 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: 22434474 BACKGROUND

• 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.

  PMID: 23571293 BACKGROUND

• 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. doi: 10.1016/j.cct.2003.08.012.

  PMID: 14662277 BACKGROUND

Related Links

• PROMIS outcome questionnaires

MeSH Terms

Interventions

Internal Fixators; External Fixators

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Results Point of Contact

• Title: Krista Brown, Clinical Research Coordinator
• Organization: Indiana University

brownkm@indiana.edu

317-963-1944

Study Officials

• Michael Zlowodzki, MD

  Indiana University Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 31, 2015
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 13, 2018
• Results First Posted: December 19, 2017

Record last verified: 2018-02

Locations

US (1)