An interventional study of Retained Surgical Sponge in Surgical Sponge, Retained, sponsored by Twin Cities Spine Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Twin Cities Spine Center · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
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
No sponge will be placed in the wound. Two radiographs will be taken of the spine (AP and Lateral views).
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.
Accuracy
Reviewer accuracy is the agreement (Cohen's Kappa) between the true condition and the readers' interpretation with 1) one lateral (LAT) image, 2) one anteroposterior (AP) image, and 3) AP and LAT images together.
Time frame: Intraoperative
Interobserver Reproducibility
Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations
Time frame: Intraoperative
Intraobserver Reproducibility
Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself
Time frame: Intraoperative
Sensitivity
Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present
Time frame: Intraoperative
Specificity
Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present
Time frame: Intraoperative
| Milestone | Retained Sponge Group | No Retained Sponge Group |
|---|---|---|
| Started | 73 | 73 |
| Completed | 56 | 55 |
| Not completed | 17 | 18 |
| Withdrew: No radiographs obtained during surgery | 17 | 18 |
Reviewer accuracy is the agreement (Cohen's Kappa) between the true condition and the readers' interpretation with 1) one lateral (LAT) image, 2) one anteroposterior (AP) image, and 3) AP and LAT images together.
| Cohen's Kappa | Lateral Image Alone | Anteroposterior Image Alone | Lateral and Anteroposterior Images Together |
|---|---|---|---|
| Accuracy | 0.76 | 0.73 | 0.80 |
Interobserver Reproducibility is the agreement (Cohen's Kappa) between observers interpretations
| Cohen's Kappa | Lateral Image Alone | Anteroposterior Image Alone | Lateral and Anteroposterior Images Together |
|---|---|---|---|
| Interobserver Reproducibility | 0.89 | 0.85 | 0.96 |
Intraobserver Reproducibility is the agreement (Cohen's Kapp) of an observer with himself
| Cohen's Kappa | Lateral Image Alone | Anteroposterior Image Alone | Lateral and Anteroposterior Images Together |
|---|---|---|---|
| Intraobserver Reproducibility | 0.91 | 0.88 | 0.96 |
Sensitivity is the percentage of all images appearing to have a sponge in which a sponge was truly present
| percentage of correct interpretations | Lateral Image Alone | Anteroposterior Image Alone | Lateral and Anteroposterior Images Together |
|---|---|---|---|
| Sensitivity | 82 | 86 | 87 |
Specificity is the percentage of all images appearing to not have a sponge in which a sponge was truly not present
| percentage of correct interpretations | Lateral Image Alone | Anteroposterior Image Alone | Lateral and Anteroposterior Images Together |
|---|---|---|---|
| Specificity | 95 | 88 | 93 |
Collected over Intraoperative. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Retained Sponge Group | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| No Retained Sponge Group | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Age, Continuous(years) | Retained Sponge Group | No Retained Sponge Group | Total |
|---|---|---|---|
| Mean | 63.2 ± 11.2 | 63.4 ± 11.3 | 63.3 ± 11.3 |
| Sex: Female, Male(Participants) | Retained Sponge Group | No Retained Sponge Group | Total |
|---|---|---|---|
| Female | 24 | 26 | 50 |
| Male | 32 | 29 | 61 |
| Race and Ethnicity Not Collected(Participants) | Retained Sponge Group | No Retained Sponge Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Body Mass Index(kg/m^2) | Retained Sponge Group | No Retained Sponge Group | Total |
|---|---|---|---|
| Median | 30.4 (19.5 to 46.0) | 29.4 (17.8 to 53.7) | 30.0 (17.8 to 53.7) |
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Plan to share: No — There is not a plan to make individual participant data (IPD) available.
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Twin Cities Spine Center