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Prospective, Observational Registry of Renaissance-guided Spine Surgeries

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ClinicalTrials.gov Identifier: NCT02212899
Recruitment Status : Terminated (Sponsor Decision)
First Posted : August 8, 2014
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Mazor Robotics

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

Condition or disease
Degenerative Spine Disease Spinal Deformity

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).


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Study Type : Observational [Patient Registry]
Actual Enrollment : 93 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Prospective, Observational Registry of Renaissance-guided Spine Surgeries
Study Start Date : February 2015
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : December 30, 2016



Primary Outcome Measures :
  1. Clinical outcomes as measured on plain radiographs [ Time Frame: Within 10 years of surgery ]
    sagittal and coronal alignment in reconstructive surgeries for spinal deformities

  2. Surgical complications [ Time Frame: Within 10 years of surgery ]
    new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss

  3. Reoperation rates [ Time Frame: Within 10 years of surgery ]
    Any revision surgery on the segment of interest

  4. Radiation exposure [ Time Frame: Day of surgery ]
    Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room


Secondary Outcome Measures :
  1. Clinical performance of instrumentation technique [ Time Frame: Day of surgery ]
    implant instrumentation time, total surgery time

  2. Ratio of executed vs. planned screws [ Time Frame: Day of surgery ]
    Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause

  3. Number of abandoned screws [ Time Frame: Day of surgery ]
    the number of screws not instrumented and the reason

  4. Neuromonitoring events [ Time Frame: Day of surgery ]
  5. Length of convalescence [ Time Frame: within 2 years of surgery ]
    Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities

  6. Improvement in health-related quality of life metrics [ Time Frame: up to 10 years post-operative ]
    back and leg VAS, Oswestry Disability Index (ODI), SRS22, EQ-5D-5L, in accordance with the surgeon's practices

  7. Fusion rates/pseudoarthrosis [ Time Frame: Within 1 year of surgery ]
    The rate of fusion as determined within one year of surgical procedure.

  8. Implant placement accuracy [ Time Frame: Within one year post-surgery ]
    Accuracy of implants as measured on a post-operative CT scan (when available)



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Ages Eligible for Study:   6 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any pediatric, adolescent or adult patient undergoing open or MIS Renaissance-guided spine surgery
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212899


Locations
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United States, Florida
Lyerly Baptist/ Lyerly Neurosurgery
Jacksonville, Florida, United States, 32207
United States, Tennessee
Tabor Orthopedics
Memphis, Tennessee, United States, 38119
United States, Texas
Spine Associates
Houston, Texas, United States, 77063
United States, Virginia
The Virginia Spine Institute
Reston, Virginia, United States, 20190
Sponsors and Collaborators
Mazor Robotics
Investigators
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Study Director: Doron Dinstein, MD, MBA Mazor Robotics

Additional Information:

Publications:

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Responsible Party: Mazor Robotics
ClinicalTrials.gov Identifier: NCT02212899     History of Changes
Other Study ID Numbers: CLN111
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: December 2016
Keywords provided by Mazor Robotics:
Spinal Surgery
Spinal Fusion
Deformity Correction
Spinal Instrumentation
Additional relevant MeSH terms:
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Spinal Diseases
Congenital Abnormalities
Bone Diseases
Musculoskeletal Diseases