Prospective, Observational Registry of Renaissance-guided Spine Surgeries

NCT02212899 | Terminated

• 1 other identifier: CLN111
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Degenerative Spine Disease; Spinal Deformity

Keywords

Spinal Surgery; Spinal Fusion; Deformity Correction; Spinal Instrumentation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Clinical performance of instrumentation technique

  Day of surgery

• Ratio of executed vs. planned screws

  Day of surgery

• Number of abandoned screws

  Day of surgery

• Neuromonitoring events

  Day of surgery

• Length of convalescence

  within 2 years of surgery

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mazor Robotics: lead

Study Sites (4)

Lyerly Baptist/ Lyerly Neurosurgery

Jacksonville, Florida, 32207, United States

Location

Tabor Orthopedics

Memphis, Tennessee, 38119, United States

Location

Spine Associates

Houston, Texas, 77063, United States

Location

The Virginia Spine Institute

Reston, Virginia, 20190, United States

Location

Related Publications (8)

• 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.

  PMID: 21602728 BACKGROUND

• 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.

  PMID: 21079498 BACKGROUND

• 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.

  PMID: 21384205 BACKGROUND

• 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.

  PMID: 22975723 BACKGROUND

• 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.

  PMID: 17268254 BACKGROUND

• 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.

  PMID: 17224800 BACKGROUND

• 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.

  PMID: 20862593 BACKGROUND

• 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.

  PMID: 21217448 BACKGROUND

Study Officials

• Doron Dinstein, MD, MBA

  Mazor Robotics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2014
• First Posted: August 8, 2014
• Study Start: February 18, 2015
• Primary Completion: December 30, 2016
• Study Completion: December 30, 2016
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

US (4)