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Intraoperative Radiographic Detection of Retained Surgical Sponges

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ClinicalTrials.gov Identifier: NCT04097678
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Allina Health System
Information provided by (Responsible Party):
Twin Cities Spine Center

Brief Summary:
This prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. The recommended practice for finding a retained sponge is by radiography. The purpose is to find out how useful plain x-rays are in open posterior lumbar spine surgery, information which is presently unavailable. The specific aim is to compare the sensitivity (seeing a sponge when one is actually present) and specificity (not seeing a sponge when one is not present) of radiography of the surgical field for three conditions: viewing one lateral radiograph versus viewing one anteroposterior radiograph versus viewing two radiographs together, one lateral and one anteroposterior.

Condition or disease Intervention/treatment Phase
Surgical Sponge, Retained Other: Retained Surgical Sponge Not Applicable

Detailed Description:
This is a prospective, randomized study with two cohorts: one experimental and one control. Anteroposterior (AP) and lateral (LAT) radiographs are routinely obtained as standard of care during spine surgery to confirm proper implant placement. These images will be used in this study. In one-half of the study subjects, after all sponges are removed, a surgical sponge will be intentionally placed in the surgical field prior to imaging. Postoperatively, each subject's images will be assessed for the presence or absence of a retained surgical sponge. Images will be independently read by two investigators. When there is discordance, the images will be adjudicated by a third. Interobserver agreement will be quantified using the Kappa statistic. Those reading images will not have participated in the surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, randomized study with two cohorts: one experimental and one control.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: This is a semi-blinded trial. Investigators performing the surgery will know whether or not a sponge is present but the investigators reviewing the images will not. Subjects will not be told which study group they are in.
Primary Purpose: Other
Official Title: Intraoperative Radiographic Detection of Retained Surgical Sponges
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Retained Sponge Group
Just prior to imaging, the surgeon will purposely place a sponge in the wound. Two radiographs will be taken of the spine (AP and Lateral views).
Other: Retained Surgical Sponge
A surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge.

No Intervention: No Retained Sponge Group
No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).



Primary Outcome Measures :
  1. Correct answers (number) [ Time Frame: Intraoperative ]
    Each subject's AP and LAT images will be viewed and the investigator will note whether or not a sponge is seen (graded present or graded absent). The investigator's answer will be compared to the true condition (actually present or actually absent). Results will be analyzed to quantify the relative specificity, sensitivity, positive and negative predictive values, and accuracy of 1) an AP image alone, 2) a LAT image alone, and 3) AP and LAT images together.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing open posterior instrumented lumbar spine surgery.
  • Read and understand English.

Exclusion Criteria:

  • Pregnancy.
  • Patients who do not consent to research.
  • Patients less than 18 years old at the time of consent.
  • Do not read and understand English.

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): NCT04097678


Contacts
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Contact: John M Dawson, PhD 612-775-6233 jmdawson@tcspine.com

Locations
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United States, Minnesota
Twin Cities Spine Center Active, not recruiting
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Twin Cities Spine Center
Allina Health System
Investigators
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Principal Investigator: Amir A Mehbod, MD Twin Cities Spine Center

Publications:
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Responsible Party: Twin Cities Spine Center
ClinicalTrials.gov Identifier: NCT04097678     History of Changes
Other Study ID Numbers: 1290533
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Twin Cities Spine Center:
lumbar spine surgery
radiographic imaging
Additional relevant MeSH terms:
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Foreign Bodies
Wounds and Injuries