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临床试验/NCT02403154
NCT02403154终止不适用

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

Indiana University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Functional Outcomes (PROMIS v1.2-Physical Function Instrument)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Internal Fixator (Procedure)

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.

干预措施: External fixator (Procedure)

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.

干预措施: Internal Fixator (Procedure)

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.

干预措施: External fixator (Procedure)

结局指标

主要结局

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

时间窗: 24 hrs - 24 months

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.

次要结局

  • 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)
  • 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)(24 hours - 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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