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

NCT01057641 | Terminated Phase 4 DMC

• 1 other identifier: PI-DLSS
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Changes in subscores for bodily pain and physical function on SF-36

  baseline, 6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

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

Spacer PROCEDURE

Implantation of a percutaneously implanted interspinous device (spacer)

Also known as: PIDLSS

Spacer

physiotherapy OTHER

physiotherapy

Also known as: PIDLSS

physiotherapy

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (2)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50931, Germany

Location

University Hospital of Cologne

Cologne, 50924, Germany

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Metered Dose Inhalers; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies; Therapeutics; Rehabilitation

Study Officials

• Thomas Kaulhausen, MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 27, 2010
• Study Start: March 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2018
• Last Updated: November 7, 2016

Record last verified: 2016-11

Locations

DE (2)