NCT03327298

Brief Summary

Background: Different methods for lumbar pedicular screw insertion have been advocated, however each technique has its cons and pros. Due to limited resources for O-Arm and navigation in our locality, the investigator was enforced to use the surgical skills to minimize the need for such advanced modalities. Aim of the study: Is to clarify the benefits of the use of free hand technique using direct visualization of the pedicles and disc space as the only guide for pedicular screw insertion using postoperative CT for evaluation of the accuracy of pedicle screw insertion. Patients and methods: One hundred and forty four screws were inserted in 32 patients using direct pedicle visualization and disc space orientation as a single intraoperative reference guide. The study was conducted in Zagazig University Hospitals from May, 2014 to June, 2015. CT was done for all patients as a direct postoperative evaluation tool.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
Last Updated

October 31, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

October 17, 2017

Last Update Submit

October 25, 2017

Conditions

Lumbar Spondylolisthesis

Keywords

Pedicle screw. Free hand. Lumbar fixation

Outcome Measures

Primary Outcomes (1)

  • pedicle screw accuracy

    Pedicle violation was assessed whether medial, inferior, lateral or superior using postoperative CT

    2 weeks

Study Arms (1)

accuracy of pedicle screw insertion

OTHER

postoperative CT lumbar spine axial and sagittal views.

Procedure: pedicle screw fixation

Interventions

pedicle screw fixationPROCEDURE

One hundred forty four screws were placed in the lumbosacral pedicles of 32 patients using free hand technique depending on direct visualization of the pedicles, roots, and intervertebral disc ( IVD) after doing full laminectomy, then postoperative CT was done for evaluation of pedicle violation.

accuracy of pedicle screw insertion

Eligibility Criteria

Age24 Years - 73 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • single level or double level degenerative spondylolisthesis

You may not qualify if:

  • other causes of spondylolisthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

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

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 31, 2017

Study Start

May 10, 2014

Primary Completion

June 5, 2015

Study Completion

June 5, 2015

Last Updated

October 31, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share