Prospective Robotic-Guided Registry of Spine Surgery (PRoGRSS)

The National Spine Health Foundation

Status: Invitation-only

Conditions: Spinal Disease

Treatments: Procedure: Robotic-guided spine surgery

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05181098

ROB-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Robotic-guided surgery group

Description:

Any pediatric, adolescent or adult patient undergoing robotic-guided spine surgery, ages 12-80.

Treatment:

Procedure: Robotic-guided spine surgery