NCT02084264

Brief Summary

To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
272

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

March 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2019

Completed
Last Updated

August 14, 2019

Status Verified

July 1, 2019

Enrollment Period

4.8 years

First QC Date

March 9, 2014

Last Update Submit

August 12, 2019

Conditions

Scoliosis

Keywords

Adolescent Idiopathic ScoliosisPediatric Scoliosis

Outcome Measures

Primary Outcomes (1)

  • Revision surgeries

    All cause revisions, including medical and surgical complications.

    1 year post-surgery

Secondary Outcomes (10)

  • Clinical performance of instrumentation technique

    Day of surgery

  • Neuromonitoring events

    Day of surgery

  • Hypoplastic pedicles

    Day of surgery

  • Improvement of radiographic and health-related quality of life metrics

    up to 10 years post-operative

  • Length of convalescence

    within 2 years of surgery

  • +5 more secondary outcomes

Study Arms (2)

Arm 1: Robotic-guided, open approach

Robotic-guided, open approach

Arm 2: control arm- non-robotic, open approach

control arm- non-robotic, open approach°

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric/adolescent patients (age 21 years and younger) undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater

You may qualify if:

  • Pediatric/adolescent patients (age 10 to 21 years), undergoing a primary surgery for the correction of a scoliotic curve of 40 degrees or greater
  • Patient capable of complying with study requirements
  • Signed informed consent by patient

You may not qualify if:

  • Scheuermann's disease
  • Infection or malignancy
  • Primary abnormalities of bones (e.g. osteogenesis imperfecta)
  • Primary muscle diseases, such as muscular dystrophy
  • Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, spina bifida, or neurofibroma)
  • Spinal cord abnormalities with any neurologic symptoms or signs
  • Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia
  • Patients who have participated in a research study involving an investigational product in the 12 weeks prior to surgery
  • Patients requiring anterior release or instrumentation
  • 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.
  • Pregnancy
  • Patient cannot follow study protocol, for any reason
  • Patient cannot or will not sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Rady Children's Hospital- San Diego

San Diego, California, 92123, United States

Location

Florida Hospital for Children

Orlando, Florida, 32801, United States

Location

Children's Healtchare of Atlanta at Scottish Rite

Atlanta, Georgia, 30342, United States

Location

Geisinger Orthopaedic Institute

Danville, Pennsylvania, 17822, United States

Location

Related Publications (1)

  • 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.

    PMID: 21079498BACKGROUND

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Doron Dinstein, MD

    Mazor Robotics

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2014

First Posted

March 11, 2014

Study Start

October 1, 2014

Primary Completion

July 8, 2019

Study Completion

July 8, 2019

Last Updated

August 14, 2019

Record last verified: 2019-07

Locations

US(4)