NCT02970578

Brief Summary

To explore the accuracy of 3D printed module assisted minimally invasive lumbar pedicle screw placement using Quandrant system, and verify its feasibility of reducing error rate of screw placement and postoperative complications.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

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

November 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2.6 years

First QC Date

November 16, 2016

Last Update Submit

November 18, 2016

Conditions

Thoracolumbar; Spina Bifida

Outcome Measures

Primary Outcomes (1)

  • Accurate rate of screw placement

    To assess whether the screw placement by 3D printed module navigation achieves the desired results. The higher value indicates the higher accuracy.

    during the operation

Secondary Outcomes (3)

  • Lumbar CT imaging

    Baseline and month 6, month 24 after surgery

  • Time of operation

    during the operation

  • Amount of intraoperative bleeding

    during the operation

Study Arms (1)

3D printed module

EXPERIMENTAL

The patients underwent 3D printed module-assisted lumbar pedicle screw placement using the Quandrant system, aiming to restore the stability of the spine.

Procedure: 3D printed module

Interventions

3D printed modulePROCEDURE

The patients underwent 3D printed module-assisted lumbar pedicle screw placement using the Quandrant system, aiming to restore the stability of the spine.

3D printed module

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Lumbar degenerative diseases as diagnosed by the criteria for diagnosis of lumbar degenerative diseases
  • Indications for internal fixation in the degenerative lumbar spine
  • Lumbar single segment or multi-segment lesions
  • Average age 63 years
  • Provision of the informed consent

You may not qualify if:

  • Lumbar spine tumors, lumbar tuberculosis, trauma fractures or joint disorders
  • Lumbar infection or acute inflammation in the other parts of the body
  • Unable to undergo lumbar surgery due to surgical contraindications (coagulation disorders) and poor cardiopulmonary function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neural Tube DefectsNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Haibin Lin, bachelor

    The Affiliated Hospital of Putian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

November 16, 2016

First Posted

November 22, 2016

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

November 1, 2015

Last Updated

November 22, 2016

Record last verified: 2016-11