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

NCT ID: NCT01057641

Last Updated: 2016-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2018-06-30

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.

Conditions

Lumbar Spinal Stenosis

Keywords

PIDLSS, Spacer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spacer

Implantation of a percutaneously implanted interspinous device ("spacer")

Group Type: EXPERIMENTAL

Spacer

Intervention Type: PROCEDURE

Implantation of a percutaneously implanted interspinous device (spacer)

physiotherapy

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.

Group Type: OTHER

physiotherapy

Intervention Type: OTHER

physiotherapy

Interventions

Spacer

Implantation of a percutaneously implanted interspinous device (spacer)

Intervention Type: PROCEDURE

physiotherapy

physiotherapy

Intervention Type: OTHER

Other Intervention Names

PIDLSS; PIDLSS

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gregor Stein

Dr. med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Kaulhausen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Cologne

Locations

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

University Hospital of Cologne

Cologne, , Germany

Countries

Germany

Other Identifiers

PI-DLSS

Identifier Type: -

Identifier Source: org_study_id