Evaluation of the Pedal-Controlled Surgistep Platform to Improve Ergonomics

NCT07140835 | Not Yet Recruiting FDA Device

• 1 other identifier: 80476
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Aim: Assess improvement in ergonomics and musculoskeletal discomfort with the Surgistep compared to a standard footstool.

Conditions

Ergonomics

Outcome Measures

Primary Outcomes (2)

• Rapid Entire Body Assessment (REBA) Scale Score

  The REBA (Rapid Entire Body Assessment) score, used to assess the risk of musculoskeletal disorders (MSDs) in work tasks, ranges from 1 to 15. A lower REBA score indicates a lower risk, with scores below 4 considered to have minimal risk. Higher scores indicate increased risk, with scores of 8 or more indicating a high risk that requires immediate attention and intervention

  During the surgery upto 60 minutes

• Rapid Upper Limb Assessment (RULA) Scale Score

  The RULA (Rapid Upper Limb Assessment) scale ranges from 1 to 7, with lower scores indicating lower risk and higher scores indicating higher risk of musculoskeletal disorders.

  During the surgery upto 60 minutes

Study Arms (2)

SurgiStep Platform

EXPERIMENTAL

The surgeon will be performing the surgery by standing over the SurgiStep Platform. The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons will be using this platform for 2 weeks, after which they will be operating on standard foot stool for 2 weeks.

Device: SurgiStep Platform; Device: Standard Foot stool

Standard surgical practice

PLACEBO COMPARATOR

The surgeon will be performing the surgery by standing over the standard of care (foot stool). The duration of the usage depends on the length of the surgery being performed by the surgeon. Surgeons use standard foot stool for 2 weeks, and switch to SurgiStep platform for 2 weeks.

Device: SurgiStep Platform; Device: Standard Foot stool

Interventions

SurgiStep Platform DEVICE

The Surgistep (pedal-controlled, adjustable platform) allows real-time height adjustment during surgery. The surgeons can adjust the height of the platform.

Standard surgical practice; SurgiStep Platform

Standard Foot stool DEVICE

Foot stool is considered as the standard of care during surgery.

Standard surgical practice; SurgiStep Platform

Eligibility Criteria

• Age: 36 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Regularly perform neurosurgical procedures (cranial/spine)
• Willing to use both devices (multiple times each).

You may not qualify if:

• Severe MSK conditions preventing device usage
• Inability/refusal to participate in observation or surveys.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Health Care

Palo Alto, California, 94305, United States

Location

Study Officials

• Atman Desai, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 26, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)