Prospective Robotic-Guided Registry of Spine Surgery

Spinal Disease Clinical Trial

— PRoGRSS  

Official title:

Prospective Robotic-Guided Registry of Spine Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05181098
• Other study ID #: ROB-002
• Status: Enrolling by invitation
• Start date: November 5, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: The National Spine Health Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to combine multi-center data of robotic assisted spine surgery, to evaluate the true scope of this advancing technology.

Description:

What is the impact on clinical and patient-reported outcomes for participants who undergo robot assisted surgery? This will be the first multi-center study to prospectively collect data on robotic assisted spine surgery outcomes. The primary objective of this study will be to facilitate quantification of potential short- and long-term benefits of robotically guided spine surgeries.

It is hypothesized that use of robotic guidance during spinal instrumentation will have numerous short- and long-term benefits to both participant and surgeon. Expected benefits include improved surgical and clinical outcomes, lower incidence of procedure-related adverse events (e.g., fewer new neurological deficits, implant-related durotomies, and implant misplacements), improved implant accuracy, lower intraoperative radiation exposure, and lower reoperation rates, when compared to the published literature.

The secondary objective of this study is to assess the clinical performance of robotic instrumentation as per the pre-operative plan. To this end, data on a number of common clinical metrics will be analyzed to determine the extent to which they are affected by the use of robotic guidance during implantation.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 80 Years

Eligibility

Inclusion Criteria:

• Any pediatric, adolescent or adult patient

• Undergoing open or MIS robotic-guided spine surgery using the Mazor Core Technology.

Exclusion Criteria:

• Pregnancy

• active infection

• malignancy

• primary abnormalities of bone

• primary muscle diseases (e.g., muscular dystrophy)

• neurologic diseases

• spinal cord abnormalities/lesions

• paraplegia.

Related Conditions & MeSH terms

• Spinal Disease
• Spinal Diseases

Intervention

Procedure:
• Robotic-guided spine surgery
The Mazor X Stealth Edition robotic platform will be used to guide posterior instrumentation during spine fusion surgery.

Locations

Country	Name	City	State
United States	National Spine Health Foundation	Reston	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
The National Spine Health Foundation	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the success of robotic-guided spine surgery, from planning to execution.	To evaluate the success from planning to execution of robotic screw placement.	1 year after surgery
Primary	To evaluate the success of robotic-guided spine surgery, by screw placement accuracy.	To determine screw accuracy	1 year after surgery
Primary	To evaluate the success of robotic-guided spine surgery, by revision surgery rates.	To determine the rate of revision surgery due to symptomatic screw malposition within 1 year	1 year after surgery
Primary	To evaluate the success of robotic-guided spine surgery, by the radiation exposure.	To determine radiation exposure to the patient and surgeon.	1 year after surgery
Secondary	To evaluate clinical outcomes, as determined by all cause revisions	To determine the rate of revision surgery for all causes within 1 year	1 year after surgery
Secondary	To evaluate clinical outcomes, by surgical complications	To determine the rate of surgical complications (wound infection/dehiscence, major neurological deficit, hemorrhage, dural tear)	1 year after surgery
Secondary	To evaluate clinical outcomes, by patient reported outcome measures	To evaluate for changes in Patient Reported Outcomes Measurement Information System (PROMIS) scores over 1 year; (PROMIS scores are calculated at T-scores on a 0-100 point scale - for positively worded functions, such as physical function and global health, the higher the score the better the outcome; but for negatively worded functions, like pain interference, the higher the score the worse the outcome).	1 year after surgery
Secondary	To evaluate clinical outcomes, by patient disability rating	To evaluate for changes in Oswestry Disability Index (ODI) scores over 1 year; disability scores range from 0-100, the higher the score the worse the outcome/disability.	1 year after surgery