← Back to Search

Surgical Theater for Cervical Spine Surgery (ISTPE Trial)

N/A

Waitlist Available

Led By Gabriel Smith, MD

Research Sponsored by University Hospitals Cleveland Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visits 1, 2, 3, 4 - 1. before 360vr consult (visit 1) 2. immediately after 360vr consult (visit 1) 3. post-op 6 weeks (visit 2) 4. post op 3 months (visit 3) 5. post op 6 month (visit 4)

Awards & highlights

ISTPE Trial Summary

This trial will test if a virtual reality platform can improve patient satisfaction and understanding in spinal surgery consults.

Eligible Conditions

Cervical Spine Surgery
Lumbar Spine Surgery

ISTPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visits 1, 2, 3, 4 - 1. before 360vr consult (visit 1) 2. immediately after 360vr consult (visit 1) 3. post-op 6 weeks (visit 2) 4. post op 3 months (visit 3) 5. post op 6 month (visit 4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visits 1, 2, 3, 4 - 1. before 360vr consult (visit 1) 2. immediately after 360vr consult (visit 1) 3. post-op 6 weeks (visit 2) 4. post op 3 months (visit 3) 5. post op 6 month (visit 4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visits 1, 2, 3, 4 - 1. before 360vr consult (visit 1) 2. immediately after 360vr consult (visit 1) 3. post-op 6 weeks (visit 2) 4. post op 3 months (visit 3) 5. post op 6 month (visit 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline EQ-5D Health-Related Quality of Life at 6 Months After Surgery

Change From Baseline Pain Disability Questionnaire (PDQ) at 6 Months After Surgery

Change in Patient Satisfaction and Understanding With HCHAPS (Hospital Consumer Assessment of Healthcare Providers and Systems) at 6 Months After Surgery

ISTPE Trial Design

1Treatment groups

Experimental Treatment

Group I: Evaluation of usefulnessExperimental Treatment1 Intervention

To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Hospitals Cleveland Medical CenterLead Sponsor

317 Previous Clinical Trials

340,250 Total Patients Enrolled

Gabriel Smith, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How extensive is the patient pool participating in this experiment?

"Affirmative. The clinical trial information hosted on clinicaltrials.gov indicates that recruitment for this medical study is ongoing; it was first posted in early January, and most recently updated in April 2022. In total, 30 patients need to be recruited from two different centres."

Answered by AI

Does this research endeavor currently have open enrollment?

"Affirmative. Clinicaltrials.gov's database indicates that this trial is actively searching for participants, having been initially posted on January 1st 2022 and recently edited April 11th 2022. 30 patients need to be sourced from two sites."

Answered by AI

Does this experiment admit individuals who have surpassed sixty years of age?

"The eligibility requirements dictate that the minimum age for enrolment is 18, while the upper cutoff sits at 89 years of age."

Answered by AI

What are the eligibility requirements for participants of this medical experiment?

"This medical trial seeks 30 participants aged between 18 and 89 who are undergoing cervical spine surgery, with the additional provisos that they must receive Surgical Theatre consultation as part of their treatment and be within the aforestated age range."

Answered by AI

Recent research and studies

NeurosurgeryJournal

Surgical Rehearsal Platform

Bambakidis, Nicholas C., Warren R. Selman, and Andrew E. Sloan. 2013. “Surgical Rehearsal Platform”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/neu.0000000000000099.

Journal of Clinical NeuroscienceJournal

Inferior Fronto-occipital Fascicle Anatomy in Brain Tumor Surgeries: From Anatomy Lab to Surgical Theater

Altieri, Roberto, Antonio Melcarne, Carola Junemann, Pietro Zeppa, Francesco Zenga, Diego Garbossa, Francesco Certo, and Giuseppe Barbagallo. 2019. “Inferior Fronto-occipital Fascicle Anatomy in Brain Tumor Surgeries: From Anatomy Lab to Surgical Theater”. Journal of Clinical Neuroscience. Elsevier BV. doi:10.1016/j.jocn.2019.07.039.

RetinaJournal

The Integrative Surgical Theater

Ehlers, Justis P., Atsuro Uchida, and Sunil K. Srivastava. 2018. “The Integrative Surgical Theater”. Retina. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/iae.0000000000001999.

clinicaltrials.govStudy