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

Lumbar Spinal Stenosis Clinical Trial

Official title:

A Clinical Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant in Comparison With the Best Non-operative Treatment of Lumbar Spine Stenosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01057641
• Other study ID #: PI-DLSS
• Status: Terminated
• Phase: Phase 4
• First received: January 26, 2010
• Last updated: November 4, 2016
• Start date: March 2011
• Est. completion date: June 2018

Study information

• Verified date: November 2016
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: June 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Male or female over 50 years of age

2. One, two, or three segment degenerative lumbar spinal stenosis (DLSS)

3. Symptoms of radiographically confirmed DLSS like leg, buttock, or groin pain with or without back pain and absence of a peripheral motoric deficit

4. Pain relief in inclination or sitting

5. Ability to walk over a distance of 50 m

6. Unsuccessful conservative therapy for 3 months under outpatient conditions

7. Informed consent

Exclusion Criteria:

1. Fixed motoric deficit

2. Cauda equina syndrome

3. Previous surgery of the lumbar spine

4. Severe osteoporosis of the vertebrae and/or of the hip

5. Spondylolisthesis more severe than Meyerding I (on scale of I-IV)

6. Metastasis of the vertebrae

7. Mentally disabled persons

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• Spacer
Implantation of a percutaneously implanted interspinous device (spacer)

Other:
• physiotherapy
physiotherapy

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne	NRW
Germany	University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in subscores for bodily pain and physical function on SF-36		baseline, 6 months	Yes
Secondary	Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ)		baseline, 6 months	Yes
Secondary	Physical function by applying ZCQ		baseline, 6 months	Yes
Secondary	Post-treatment patient satisfaction by applying ZCQ		baseline, 6 months	Yes
Secondary	General health status (Quality of life) by applying SF-36		baseline, 6 months	Yes
Secondary	Measurement of walking distance		baseline, 6 months	No