NCT02558621

Brief Summary

The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

September 23, 2015

Last Update Submit

May 9, 2016

Conditions

Degenerative Disc DiseaseSpinal StenosisSpondylolisthesisSpondylosis

Keywords

Robotic Spinal Fusion Surgery

Outcome Measures

Primary Outcomes (1)

  • clinical acceptance of the performance of the AQrate Robotic Assistance System.

    The acceptance of the performance of the AQrate System will be measured by scale given to total of 8 questions.

    Day of surgery

Secondary Outcomes (2)

  • Intraoperative exposure to radiation

    Day of surgery

  • Accuracy of spinal screws placed

    Within one month of surgery

Study Arms (1)

Device: AQrate Robotic Assistance System

EXPERIMENTAL

Precise positioning of surgical instruments and spinal implants during general spinal surgery.

Device: AQrate Robotic Assistance System

Interventions

AQrate Robotic Assistance SystemDEVICE

Robotic guidance during spinal fusion surgery

Device: AQrate Robotic Assistance System

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age from 18 years to 85 years) scheduled for spinal fusion surgery,
  • Primary spinal surgery (It is the first surgery on this patient's spine)
  • Patient is capable of complying with study requirements, and
  • Patient is willing to provide a signed informed consent.

You may not qualify if:

  • Pregnancy and lactation
  • Simultaneous participation in other clinical studies
  • Infection or malignancy
  • Previous spondylodesis
  • Previous spinal surgical procedures
  • Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, neurofibroma)
  • Spinal cord abnormalities with any neurologic symptoms or signs
  • Paraplegia
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants 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
  • Patients in emergency situation, are not legally competent, cannot understand the situation,
  • Pediatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinic Genolier

Genolier, Canton of Vaud, 1272, Switzerland

Location

Hôpital du Valais

Sion, Valais, 1951, Switzerland

Location

Related Publications (1)

  • Kostrzewski S, Duff JM, Baur C, Olszewski M. Robotic system for cervical spine surgery. Int J Med Robot. 2012 Jun;8(2):184-90. doi: 10.1002/rcs.446. Epub 2011 Dec 21.

    PMID: 22190547BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal StenosisSpondylolisthesisSpondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysis

Study Officials

  • Jean-Denis Patet, MD

    Clinic Genolier, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2015

First Posted

September 24, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-05

Locations

CH(2)