Study on the Treatment of Degenerative Lumbar Spine Steno... | NCT01057641

Studies
Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant

NCT01057641

Sponsor

University of Cologne

Status

Terminated

Last Update Posted

Nov 7, 2016Estimated

Enrollment

22Actual

Phase

Phase 4

Conditions

Lumbar Spinal Stenosis

Interventions

Spacer
physiotherapy

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

low enrollment

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

May 2016Actual

Completion Date

Jun 2018Estimated

First Submitted Date

Jan 26, 2010

First Submission Date that Met QC Criteria

Jan 26, 2010

First Posted Date

Jan 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2016

Last Update Posted Date

Nov 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Neurogenic intermittent claudication is a specific symptom complex occurring in patients with lumbar spinal stenosis. Characteristic of this disease is the occurrence of increasing leg, buttock or groin pain with or without lower back pain when walking a certain distance or reclining. Bending forward or sitting leads to a rapid pain relief. Lumbar spinal stenosis is defined as a reduction of the diameter of the spinal canal. The mechanism leading to stenosis is a remodeling and overgrowth of the spinal canal with osteophyte formation. Any loss of tissue or decrease of the disc height results in a relative laxity of the ligament structures and accelerates the degeneration of the spinal joints. As a therapy option, conservative therapy with oral analgesics and physical therapy is considered. This treatment can be intensified by adding epidural pain treatment. Is the conservative treatment not successful surgical intervention is necessary. In patients over 65 years of age operative decompression of the lumbar spinal stenosis constitutes the most common surgical operation of the spine. A relatively new therapy alternative is the interspinous process decompression (IPD). Studies have shown that the IPDs prevent narrowing of the spinal canal and neural foramens. The study is intended as a randomised, monocentre study to investigate the safety and the benefit of a minimally invasive percutaneous IPD-device in comparison with the best non-surgical operative treatment of lumbar spinal stenosis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spacer	Experimental	Implantation of a percutaneously implanted interspinous device ("spacer")	Procedure: Spacer
physiotherapy	Other	The control group will receive at least physiotherapy and physical therapy (e.g. massage and fango). Under inpatient conditions therapy will last for seven days. After discharge physical therapy has to be continued for 5 weeks. A schedule will ensure the consistency of the physical therapy. The inpatient-treatment can be repeated every 6 months if necessary.	Other: physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spacer	Procedure	Implantation of a percutaneously implanted interspinous device (spacer)	Spacer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in subscores for bodily pain and physical function on SF-36		baseline, 6 months

Secondary Outcomes

Measure	Description	Time Frame
Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ)		baseline, 6 months
Physical function by applying ZCQ		baseline, 6 months
Post-treatment patient satisfaction by applying ZCQ

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female over 50 years of age
One, two, or three segment degenerative lumbar spinal stenosis (DLSS)
Symptoms of radiographically confirmed DLSS like leg, buttock, or groin pain with or without back pain and absence of a peripheral motoric deficit
Pain relief in inclination or sitting
Ability to walk over a distance of 50 m
Unsuccessful conservative therapy for 3 months under outpatient conditions
Informed consent

Exclusion Criteria:

Fixed motoric deficit
Cauda equina syndrome
Previous surgery of the lumbar spine
Severe osteoporosis of the vertebrae and/or of the hip
Spondylolisthesis more severe than Meyerding I (on scale of I-IV)
Metastasis of the vertebrae
Mentally disabled persons

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Kaulhausen, MD	University Hospital of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Cologne		Cologne	North Rhine-Westphalia	50931	Germany
University Hospital of Cologne

Condition Browse Module

MeSH Terms

ID	Term
D013130	Spinal Stenosis

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D036501	Metered Dose Inhalers
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D009330	Nebulizers and Vaporizers
D004864	Equipment and Supplies
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided