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

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

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.

Study Overview

• Status: Terminated
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: physiotherapy; Procedure: Spacer

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany, 50924
    • University Hospital of Cologne
  • NRW
    • Cologne, NRW, Germany, 50931
      • University Hospital Cologne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spacer; Implantation of a percutaneously implanted interspinous device ("spacer")	Procedure: Spacer; Implantation of a percutaneously implanted interspinous device (spacer); Other Names: PIDLSS
Other: 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.	Other: physiotherapy; physiotherapy; Other Names: PIDLSS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	baseline, 6 months
General health status (Quality of life) by applying SF-36	baseline, 6 months
Measurement of walking distance	baseline, 6 months

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Thomas Kaulhausen, MD, University Hospital of Cologne

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): May 1, 2016
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: January 26, 2010
• First Submitted That Met QC Criteria: January 26, 2010
• First Posted (Estimate): January 27, 2010

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: PIDLSS, Spacer
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: PI-DLSS