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Anterior Pelvic Ring FracturesNCT02403154

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

A study testing Internal Fixator and External fixator in people with Anterior Pelvic Ring Fractures, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Anterior Pelvic Ring Fractures
What is being tested?
Internal Fixator and External fixator
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Apr 2014to Jun 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Prospective Randomized Comparison of Subcutaneous Internal Fixation and External Fixation for Anterior Pelvic Ring Fractures Requiring Stabilization

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.

Read the detailed description

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. This type of injury requires follow up at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. At each follow up appointment, the patient will be asked to complete surveys as part of the PROMIS series (Patient Reported Outcomes Measurement Information System) which will include surveys about physical function, pain, mobility, sex life satisfaction, depression, and for male patients, a survey about erectile function. In addition to the PROMIS questionnaire for pain, the investigators will also use a visual analogue pain scale and ask what the patient's satisfaction is on a scale of 0-100%. If the patient does not report to clinic for follow up, the research coordinator will call the patient to complete the study questionnaires.

Being tested
Internal Fixator, External fixator
Keywords
Anterior pelvic ring, Internal fixation, External fixation, Orthopaedic, Orthopedic, pubic rami

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internal FixatorProcedure or surgery

    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.

  • External fixatorProcedure or surgery

    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.

Study groups in NCT02403154
Study groupRoleWhat they receive
Randomized to Internal FixatorExperimentalPatient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be internal fixator.
Receives: Procedure: Internal Fixator
Randomized to External FixatorExperimentalPatient signed consent and agreed to have their treatment method randomized and the randomization system determined that their surgical intervention will be external fixator.
Receives: Procedure: External fixator
Observational - Internal FixatorOtherPatient 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.
Receives: Procedure: Internal Fixator
Observational - External FixatorOtherPatient 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.
Receives: Procedure: External fixator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hrs - 24 months

Secondary outcomes (6)
  1. Implant Breakage or Failure Rates

    We will compare the implant failure/breakage rate between the two interventions.

    Measured: 24 hours - 24 months

  2. Infection Rates

    We will compare the rate of infection between the two interventions.

    Measured: 24 hours - 24 months

  3. Revision Surgery Rates

    We will compare the revision surgery rates between the two interventions.

    Measured: 24 hours - 24 months

  4. Health-related Qualify of Life

    We will ask patients multiple questionnaires to assess their quality of life after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function.

    Measured: 24 hours - 24 months

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

    We will evaluate factors such as age, gender, BMI, additional injuries to see if they help predict outcome

    Measured: 24 hours - 24 months

  6. Compare the Functional Outcome Scores (PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction With Sex Life, PROMIS Depression, Majeed Score, SF-12, VAS, Patient Satisfaction Score, and (Only in Men) PROMIS Erectile Function)

    We will ask patients multiple questionnaires to asses their functional outcomes after surgery. These questionnaires include: PROMIS Pain Interference, PROMIS Mobility, PROMIS Global Satisfaction with Sex Life, PROMIS Depression, Majeed score, SF-12, VAS, patient satisfaction score, and (only in men) PROMIS Erectile Function.

    Measured: 24 hours - 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2016
  4. Study completionJun 2016

Why it stopped: Principle Investigator left institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02403154
Sponsor's protocol ID
1404651343
Status last verified
Feb 2018
First submitted
23 Mar 2015
Last updated
13 Mar 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11110141
  • 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.

    PubMed 16132252
  • 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.

    PubMed 9680022
  • 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.

    PubMed 10615965
  • 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.

    PubMed 2380212
  • Mears DC, Fu FH. Modern concepts of external skeletal fixation of the pelvis. Clin Orthop Relat Res. 1980 Sep;(151):65-72.

    PubMed 7418325
  • 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.

    PubMed 11130512
  • 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.

    PubMed 2925751
  • 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.

    PubMed 8230327
  • 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.

    PubMed 7118964
  • 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.

    PubMed 22357081
  • 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.

    PubMed 22048189
  • 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.

    PubMed 22383020
  • 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.

    PubMed 22337488
  • 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.

    PubMed 22048183

Questions about this trial

What is this clinical trial studying?

A study testing Internal Fixator and External fixator in people with Anterior Pelvic Ring Fractures, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Outcomes (PROMIS v1.2-Physical Function Instrument) (time frame: 24 hrs - 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02403154, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2018.

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