NCT03388307

Brief Summary

The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Status
unknown

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

December 19, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

January 3, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

December 19, 2017

Last Update Submit

January 1, 2018

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • back pain

    visual analog scale

    one year

Secondary Outcomes (1)

  • neurogenic claudication pain

    one year

Study Arms (2)

unilateral laminotomy

EXPERIMENTAL

patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression

Procedure: unilateral laminotomy

decompressive laminectomy

EXPERIMENTAL

patients with lumbar canal stenosis who undergo decompressive laminectomy

Procedure: decompressive laminectomy

Interventions

unilateral laminotomyPROCEDURE

minimally invasive technique

unilateral laminotomy
decompressive laminectomyPROCEDURE

classic surgery

decompressive laminectomy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age:40-80 years
  • sex:both sexes
  • symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
  • radiologically confirmed LSS , caused by degenerative changes
  • canal stenosis at a maximum of 2 levels

You may not qualify if:

  • were to undergo a concomitant fusion or instrumentation placement;
  • had had previous lumbar surgeries at the same level;
  • had spondylolisthesis of any grade or degenerative scoliosis;
  • had evidence of instability on dynamic radiographs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor of neurosurgery

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 2, 2018

Study Start

January 15, 2018

Primary Completion

November 1, 2018

Study Completion

November 15, 2018

Last Updated

January 3, 2018

Record last verified: 2018-01