NCT01727752

Brief Summary

A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
386

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

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

October 1, 2007

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

7.7 years

First QC Date

November 12, 2012

Last Update Submit

March 29, 2016

Conditions

Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

  • Zurich Claudication Questionnaire (ZCQ)

    ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.

    5 years

Secondary Outcomes (7)

  • EuroQOL (EQ-5D)

    5 years

  • MRDQ

    5 years

  • SF-36

    5 years

  • McGill Pain Questionnaire

    5 years

  • VAS Leg Pain

    5 years

  • +2 more secondary outcomes

Study Arms (2)

Surgical decompression

ACTIVE COMPARATOR

Surgical decompression

Procedure: Decompression

coflex Interlaminar Technology

ACTIVE COMPARATOR

Surgical decompression followed by implantation of coflex Interlaminar Technology.

Procedure: Decompression

Interventions

DecompressionPROCEDURE
Surgical decompressioncoflex Interlaminar Technology

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent
  • is 40 to 85 years old at time of surgery
  • has INC, as noted by leg/buttock/groin pain with or without back pain. Leg/buttock/groin pain needs to be strongly relieved when flexed such as when sitting in a chair
  • has received at least three months of conservative care therapy which may have included, but is not limited to, physical therapy, bracing, systemic and/or injected medications
  • has a regular indication for surgical intervention of INC
  • has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI
  • is physically and mentally willing and able to comply with, or has a caregiver who is willing and able to comply with, the post-operative evaluations.

You may not qualify if:

  • has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)
  • has Paget's disease, severe osteoporosis or metastasis to the vertebrae
  • has significant scoliosis (Cobb angle \> 25 degrees)
  • has a Body Mass Index (BMI) \> 40 kg/m2
  • has had any surgery of the lumbar spine
  • has degenerative spondylolisthesis \> grade 1 (on a scale 1 to 4) at the affected level
  • has significant instability of the lumbar spine
  • has severe comorbid conditions that will increase the risk to the patient or interfere with the evaluability of this study
  • has a fused segment at the indicated level.
  • has a herniated disk on the level of interest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Sint Lucas Andreas Ziekenhuis

Amsterdam, Netherlands

Location

Reinier De Graaf Gasthuis

Delft, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Medical Center Alkmaar

Holland, Netherlands

Location

Diaconessenhuis

Leiden, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Rijnland ziekenhuis,

Leiderdorp, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Vlietland Ziekenhuis

Schiedam, Netherlands

Location

Bronovo Ziekenhuis

The Hague, Netherlands

Location

HAGA ziekenhuis

The Hague, Netherlands

Location

Medical Center Haaglanden

The Hague/Leidschendam, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

MeSH Terms

Interventions

Decompression

Intervention Hierarchy (Ancestors)

TherapeuticsPressureMechanical PhenomenaPhysical Phenomena

Study Design

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

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 16, 2012

Study Start

October 1, 2007

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

NL(13)