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Degenerative Spine DiseaseNCT02212899

Prospective, Observational Registry of Renaissance-guided Spine Surgeries

An observational study of Degenerative Spine Disease and Spinal Deformity, run by Mazor Robotics at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries. Read more about this study

Who is it for?
Ages 6 to 90 years
Conditions the study is for
Degenerative Spine Disease, Spinal Deformity
How many people
93 participants
Where
4 sitesUnited States
Study dates
18 Feb 2015to 30 Dec 2016
How long will I take part?
10 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Spine Associates

    Houston, Texas, 77063

  • Lyerly Baptist/ Lyerly Neurosurgery

    Jacksonville, Florida, 32207

  • Tabor Orthopedics

    Memphis, Tennessee, 38119

  • The Virginia Spine Institute

    Reston, Virginia, 20190

Other trials in United States

About this study

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

Read the 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).

Keywords
Spinal Surgery, Spinal Fusion, Deformity Correction, Spinal Instrumentation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical outcomes as measured on plain radiographs

    sagittal and coronal alignment in reconstructive surgeries for spinal deformities

    Measured: Within 10 years of surgery

  2. Surgical complications

    new neural deficits, implant-related durotomy, infection requiring return to surgery, excessive blood loss

    Measured: Within 10 years of surgery

  3. Reoperation rates

    Any revision surgery on the segment of interest

    Measured: Within 10 years of surgery

  4. Radiation exposure

    Reading of exposure in seconds (and KvP if available) from C-arm or other imaging system used in the operating room

    Measured: Day of surgery

Secondary outcomes (8)

  1. Clinical performance of instrumentation technique

    implant instrumentation time, total surgery time

    Measured: Day of surgery

  2. Ratio of executed vs. planned screws

    Number of screws planned for Renaissance-guided insertion, but instead inserted manually, and cause

    Measured: Day of surgery

  3. Number of abandoned screws

    the number of screws not instrumented and the reason

    Measured: Day of surgery

  4. Neuromonitoring events

    Measured: Day of surgery

  5. Length of convalescence

    Length of hospital stay, destination at discharge, time to return to work, time to return to normal activities

    Measured: within 2 years of surgery

  6. 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

    Measured: up to 10 years post-operative

  7. Fusion rates/pseudoarthrosis

    The rate of fusion as determined within one year of surgical procedure.

    Measured: Within 1 year of surgery

  8. Implant placement accuracy

    Accuracy of implants as measured on a post-operative CT scan (when available)

    Measured: Within one year post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2014 (estimated)
  2. Study start18 Feb 2015
  3. Primary completion30 Dec 2016
  4. Study completion30 Dec 2016

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
93 participants (actual)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02212899
Sponsor's protocol ID
CLN111
Status last verified
Sep 2020
First submitted
11 May 2014
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21602728

  • 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.

    PubMed 21079498

  • 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.

    PubMed 21384205

  • 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.

    PubMed 22975723

  • 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.

    PubMed 17268254

  • 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.

    PubMed 17224800

  • 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.

    PubMed 20862593

  • 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.

    PubMed 21217448

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Spine Disease and Spinal Deformity, run by Mazor Robotics at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical outcomes as measured on plain radiographs (time frame: Within 10 years of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02212899, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.

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