Prospective, Observational Registry of Renaissance-guided Spine Surgeries

To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.

Study Overview

• Status: Terminated
• Conditions: Spinal Deformity; Degenerative Spine Disease

Detailed Description

The key objective of this observational registry is to prospectively collect data to facilitate the quantification of potential short- and long-term benefits of Renaissance-guided spine surgery. It establishes a common framework for collaboration between surgeons performing Renaissance-guided spine surgeries in either minimally invasive (MIS) or open surgical approaches.

The main endpoints that will be collected are surgical endpoints (e.g. complication rates), patient reported outcomes (e.g. VAS, ODI), imaging parameters (e.g. coronal and sagittal alignment, mainly in reconstructive surgeries for spinal deformities) and technical parameters (e.g. use of intraoperative fluoroscopy, ratio of planned vs. executed screws).

• Study Type: Observational
• Enrollment (Actual): 93

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Lyerly Baptist/ Lyerly Neurosurgery
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Tabor Orthopedics
  • Texas
    • Houston, Texas, United States, 77063
      • Spine Associates
  • Virginia
    • Reston, Virginia, United States, 20190
      • The Virginia Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 90 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any pediatric, adolescent or adult patient undergoing open or MIS Renaissance-guided spine surgery

Description

Inclusion Criteria:

Patients undergoing spinal surgery in a posterior approach where the surgeon used Renaissance surgical guidance system.

Patient capable of complying with study requirements. Signed informed consent by patient.

Exclusion Criteria:

Any significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study.

Patient cannot follow study protocol, for any reason. Patient cannot or will not sign informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcomes as measured on plain radiographs	sagittal and coronal alignment in reconstructive surgeries for spinal deformities	Within 10 years of surgery
Surgical complications	new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss	Within 10 years of surgery
Reoperation rates	Any revision surgery on the segment of interest	Within 10 years of surgery
Radiation exposure	Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance of instrumentation technique	implant instrumentation time, total surgery time	Day of surgery
Ratio of executed vs. planned screws	Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause	Day of surgery
Number of abandoned screws	the number of screws not instrumented and the reason	Day of surgery
Neuromonitoring events		Day of surgery
Length of convalescence	Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities	within 2 years of surgery
Improvement in health-related quality of life metrics	back and leg VAS, Oswestry Disability Index (ODI), SRS22, EQ-5D-5L, in accordance with the surgeon's practices	up to 10 years post-operative
Fusion rates/pseudoarthrosis	The rate of fusion as determined within one year of surgical procedure.	Within 1 year of surgery
Implant placement accuracy	Accuracy of implants as measured on a post-operative CT scan (when available)	Within one year post-surgery

Collaborators and Investigators

• Sponsor: Mazor Robotics
• Investigators: Study Director: Doron Dinstein, MD, MBA, Mazor Robotics

Publications and helpful links

General Publications

• Rajasekaran S, Vidyadhara S, Ramesh P, Shetty AP. Randomized clinical study to compare the accuracy of navigated and non-navigated thoracic pedicle screws in deformity correction surgeries. Spine (Phila Pa 1976). 2007 Jan 15;32(2):E56-64. doi: 10.1097/01.brs.0000252094.64857.ab.
• Lieberman IH, Hardenbrook MA, Wang JC, Guyer RD. Assessment of pedicle screw placement accuracy, procedure time, and radiation exposure using a miniature robotic guidance system. J Spinal Disord Tech. 2012 Jul;25(5):241-8. doi: 10.1097/BSD.0b013e318218a5ef.
• Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stuer C, Burger R, Maeurer J, Donald GD, Schoenmayr R, Friedlander A, Knoller N, Schmieder K, Pechlivanis I, Kim IS, Meyer B, Shoham M. Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study. Spine (Phila Pa 1976). 2010 Nov 15;35(24):2109-15. doi: 10.1097/BRS.0b013e3181d323ab. Erratum In: Spine (Phila Pa 1976). 2011 Jan 1;36(1):91. Gordon, Donald G [corrected to Donald, Gordon D].
• Kantelhardt SR, Martinez R, Baerwinkel S, Burger R, Giese A, Rohde V. Perioperative course and accuracy of screw positioning in conventional, open robotic-guided and percutaneous robotic-guided, pedicle screw placement. Eur Spine J. 2011 Jun;20(6):860-8. doi: 10.1007/s00586-011-1729-2. Epub 2011 Mar 8.
• Hu X, Ohnmeiss DD, Lieberman IH. Robotic-assisted pedicle screw placement: lessons learned from the first 102 patients. Eur Spine J. 2013 Mar;22(3):661-6. doi: 10.1007/s00586-012-2499-1. Epub 2012 Sep 14.
• Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine (Phila Pa 1976). 2007 Feb 1;32(3):E111-20. doi: 10.1097/01.brs.0000254048.79024.8b.
• Tian NF, Huang QS, Zhou P, Zhou Y, Wu RK, Lou Y, Xu HZ. Pedicle screw insertion accuracy with different assisted methods: a systematic review and meta-analysis of comparative studies. Eur Spine J. 2011 Jun;20(6):846-59. doi: 10.1007/s00586-010-1577-5. Epub 2010 Sep 23.
• Hamilton DK, Smith JS, Sansur CA, Glassman SD, Ames CP, Berven SH, Polly DW Jr, Perra JH, Knapp DR, Boachie-Adjei O, McCarthy RE, Shaffrey CI; Scoliosis Research Society Morbidity and Mortality Committee. Rates of new neurological deficit associated with spine surgery based on 108,419 procedures: a report of the scoliosis research society morbidity and mortality committee. Spine (Phila Pa 1976). 2011 Jul 1;36(15):1218-28. doi: 10.1097/BRS.0b013e3181ec5fd9.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2015
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): December 30, 2016

Study Registration Dates

• First Submitted: May 11, 2014
• First Submitted That Met QC Criteria: August 6, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Spinal Fusion; Spinal Surgery; Deformity Correction; Spinal Instrumentation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Congenital Abnormalities; Spinal Diseases
• Other Study ID Numbers: CLN111