Prospective, Observational Registry of Renaissance-guided Spine Surgeries

Spinal Deformity Clinical Trial

Official title:

Prospective, Observational Registry of Renaissance-guided Spine Surgeries

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02212899
• Other study ID #: CLN111
• Status: Terminated
• Start date: February 18, 2015
• Est. completion date: December 30, 2016

Study information

• Verified date: September 2020
• Source: Mazor Robotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: December 30, 2016
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Degenerative Spine Disease
• Spinal Deformity
• Spinal Diseases

Locations

Country	Name	City	State
United States	Spine Associates	Houston	Texas
United States	Lyerly Baptist/ Lyerly Neurosurgery	Jacksonville	Florida
United States	Tabor Orthopedics	Memphis	Tennessee
United States	The Virginia Spine Institute	Reston	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Mazor Robotics

Country where clinical trial is conducted

United States, 

References & Publications (8)

Devito DP, Kaplan L, Dietl R, Pfeiffer M, Horne D, Silberstein B, Hardenbrook M, Kiriyanthan G, Barzilay Y, Bruskin A, Sackerer D, Alexandrovsky V, Stüer 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]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine (Phila Pa 1976). 2007 Feb 1;32(3):E111-20. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes as measured on plain radiographs	sagittal and coronal alignment in reconstructive surgeries for spinal deformities	Within 10 years of surgery
Primary	Surgical complications	new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss	Within 10 years of surgery
Primary	Reoperation rates	Any revision surgery on the segment of interest	Within 10 years of surgery
Primary	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	Clinical performance of instrumentation technique	implant instrumentation time, total surgery time	Day of surgery
Secondary	Ratio of executed vs. planned screws	Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause	Day of surgery
Secondary	Number of abandoned screws	the number of screws not instrumented and the reason	Day of surgery
Secondary	Neuromonitoring events		Day of surgery
Secondary	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
Secondary	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
Secondary	Fusion rates/pseudoarthrosis	The rate of fusion as determined within one year of surgical procedure.	Within 1 year of surgery
Secondary	Implant placement accuracy	Accuracy of implants as measured on a post-operative CT scan (when available)	Within one year post-surgery