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Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fracture

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ClinicalTrials.gov Identifier: NCT03647410
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Hebei Medical University Third Hospital

Brief Summary:
Patients of unilaterally displaced sacral fractures fixed with lumbopelvic technique or novel adjustable plate from June 2011 to June 2017 were recruited into this study and were divided into two groups: group A (lumbopelvic fixation) and groups B (novel adjustable plate). Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications were reviewed. Fracture healing was assessed by the radiographs conducted at follow-up. Functional outcome was evaluated according to the Majeed score at the final follow-up.

Condition or disease Intervention/treatment
Reduction Deformity of Limb Device: lumbopelvic fixation

Detailed Description:
Patients of unilateral displaced sacral fractures from June 2011 to June 2017 were recruited into this study. The inclusion criteria were as follows: 18-65 years, with normal activity ability before injury, fixed with lumbopelvic technique or novel adjustable plate, completed more than a year follow-up. The exclusion criteria were as follows: pathologic fractures, open fractures, associated with other severe injuries (traumatic brain injury), risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) and non-completion of one-year follow-up. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, related complications were reviewed. Reduction quality was assessed on the postoperative radiographs and CT scans. Functional outcome was evaluated according to the Majeed score system at the final follow-up.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Lumbopelvic Fixation Versus Novel Adjustable Plate for Displaced Sacral Fractures: A Retrospective Cohort Study
Actual Study Start Date : June 2011
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
lumbopelvic fixation
sacral fractures fixed with lumbopelvic fixation
novel adjustable plate
sacral fractures fixed with novel adjustable plate
Device: lumbopelvic fixation
Sacral fractures fixed with lumbopelvic fixation or novel adjustable plate were divided into two groups. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications, and functional outcome were reviewed.
Other Name: novel adjustable plate




Primary Outcome Measures :
  1. postoperative reduction quality of sacral fractures after different surgical techniques [ Time Frame: 1 year ]
    maximum displacement distance of the sacral fracture in the postoperative CT scans


Secondary Outcome Measures :
  1. the incidence of complication [ Time Frame: 1 year ]
    the incidence of wound infection, iatrogenic injury of vessels and nerves, nonunion



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients of unilateral displaced sacral fractures from June 2011 to June 2017 were recruited into this study. The inclusion criteria were as follows: 18-65 years, with normal activity ability before injury, fixed with lumbopelvic technique or novel adjustable plate, completed more than a year follow-up. The exclusion criteria were as follows: pathologic fractures, open fractures, associated with other severe injuries (traumatic brain injury), risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases) and non-completion of one-year follow-up.
Criteria

Inclusion Criteria:

  • 18-65 years, with normal activity ability before injury
  • Fixed with lumbopelvic technique or novel adjustable plate
  • Completed more than a year follow-up

Exclusion Criteria:

  • Pathologic fractures
  • Open fractures
  • Associated with other severe injuries (traumatic brain injury)
  • Risk factors affecting bone healing (osteoporosis, smoking, and metabolic diseases)
  • Non-completion of one-year follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647410


Contacts
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Contact: Ruipeng Zhang +8615613390624 zhangruipengdoctor@126.com

Locations
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China, Hebei
Hebei Medical University Third Hospital Recruiting
Shijiazhuang, Hebei, China, 050051
Contact: Yingze Zhang, M.D    +8613313012888    yzzhangdr@126.com   
Sponsors and Collaborators
Hebei Medical University Third Hospital
Investigators
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Principal Investigator: Ruipeng Zhang Third Hospital of Hebei Medical University Department of Orthopaedic Surgery

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Responsible Party: Hebei Medical University Third Hospital
ClinicalTrials.gov Identifier: NCT03647410     History of Changes
Other Study ID Numbers: RPZ2018
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No