NCT02441959

Brief Summary

The purpose of this study is to compare the clinical and radiographic outcomes of full endoscopic lumbar discectomy versus open lumbar decompression for the treatment of lumbar herniated discs in which the patient's leg pain is greater than back pain.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

April 23, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

3.1 years

First QC Date

April 23, 2015

Last Update Submit

August 3, 2018

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

  • Leg pain as assessed by VAS score

    2 years

Study Arms (3)

Endoscopic Discectomy

ACTIVE COMPARATOR

Randomized to Endoscopic Discectomy Lumbar discectomy Endoscopic Intervention type is lumbar endoscopic surgery- no device or drug

Procedure: Lumbar discectomy Endoscopic

Open Discectomy

ACTIVE COMPARATOR

Randomized to Open Discectomy Lumbar discectomy Open Intervention type is lumbar open surgery- no device or drug

Procedure: Lumbar discectomy Open

Open Discectomy-Cross Over Arm

OTHER

Randomized to Endoscopic Discectomy Cross over to lumbar discectomy open based on surgeons assessment pre or post incision Intervention type is lumbar open surgery- no device or drug

Procedure: Lumbar discectomy Open

Interventions

Lumbar discectomy OpenPROCEDURE

Open Discectomy

Also known as: Intervention type is lumbar Open surgery- no device or drug
Open DiscectomyOpen Discectomy-Cross Over Arm
Lumbar discectomy EndoscopicPROCEDURE

Endoscopic Discectomy

Also known as: (Intervention type is lumbar endoscopic surgery- no device or drug
Endoscopic Discectomy

Eligibility Criteria

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

You may qualify if:

  • Patient equal to or greater than 18 years old.
  • Patients with single level para-central herniated discs from L1-S1.
  • VAS (Visual Analog Scale) leg \> 40 mm.
  • Leg pain must be greater than back pain.
  • Minimum 6 weeks conservative treatment unless motor strength U\< U4/5 and or deteriorating neurologic function.

You may not qualify if:

  • Lateral/subarticular, far lateral disc herniations
  • Multi-focal (multi modal) disc herniations
  • Symptomatic multiple level disc herniations
  • Active infection either spinal or otherwise
  • Prior history of lumbar spinal infection at any level
  • Spinal tumor in lumbar region
  • Dynamic (any grade) or fixed spondylolisthesis more than 3mm
  • Disc extrusion that is more superior than most inferior aspect of superior pedicle above index disc level
  • Disc extrusion that is more inferior than the middle aspect of inferior pedicle below the index disc level
  • Presence of unilateral or bilateral pars inter articularis defects (spondylolysis)
  • Disc herniation which is significantly calcified
  • Contra-lateral leg pain U\>40 mm
  • History of peripheral diabetic neuropathy
  • Significant central stenosis with history of neurogenic claudication
  • Pregnancy
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • James J Yue, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 12, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

US(1)