Clinical trial NCT02212899: Prospective, Observational Registry of Renaissance-guided Spine Surgeries
Official title: Prospective, Observational Registry of Renaissance-guided Spine Surgeries
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Degenerative Spine Disease
Spinal Deformity
Keywords: Spinal Surgery
Spinal Fusion
Deformity Correction
Spinal Instrumentation
Lead sponsor: Mazor Robotics
Sponsor class: INDUSTRY
First posted: 2014-08-08
Enrollment: 93
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pediatric, adolescent or adult patient undergoing open or MIS Renaissance-guided spine surgery

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical outcomes as measured on plain radiographs
timeFrame: Within 10 years of surgery
measure: Surgical complications
timeFrame: Within 10 years of surgery
measure: Reoperation rates
timeFrame: Within 10 years of surgery
measure: Radiation exposure
timeFrame: Day of surgery
Secondary outcomes:
measure: Clinical performance of instrumentation technique
timeFrame: Day of surgery
measure: Ratio of executed vs. planned screws
timeFrame: Day of surgery
measure: Number of abandoned screws
timeFrame: Day of surgery
measure: Neuromonitoring events
timeFrame: Day of surgery
measure: Length of convalescence
timeFrame: within 2 years of surgery
measure: Improvement in health-related quality of life metrics
timeFrame: up to 10 years post-operative
measure: Fusion rates/pseudoarthrosis
timeFrame: Within 1 year of surgery
measure: Implant placement accuracy
timeFrame: Within one year post-surgery
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Lyerly Baptist/ Lyerly Neurosurgery
state: Florida
city: Memphis
country: United States
facility: Tabor Orthopedics
state: Tennessee
city: Houston
country: United States
facility: Spine Associates
state: Texas
city: Reston
country: United States
facility: The Virginia Spine Institute
state: Virginia
Study officials:
affiliation: Mazor Robotics
name: Doron Dinstein, MD, MBA
role: STUDY_DIRECTOR
References:
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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.
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.
citation: 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.
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. doi: 10.1097/01.brs.0000252094.64857.ab.
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.
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.