Study on the Treatment of Degenerative Lumbar Spine Stenosis With a Percutaneous Interspinous Implant
Keywords
Abstract
Dates
Last Verified: | 10/31/2016 |
First Submitted: | 01/25/2010 |
Estimated Enrollment Submitted: | 01/25/2010 |
First Posted: | 01/26/2010 |
Last Update Submitted: | 11/03/2016 |
Last Update Posted: | 11/06/2016 |
Actual Study Start Date: | 02/28/2011 |
Estimated Primary Completion Date: | 04/30/2016 |
Estimated Study Completion Date: | 05/31/2018 |
Condition or disease
Intervention/treatment
Procedure: Spacer
Other: physiotherapy
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Spacer Implantation of a percutaneously implanted interspinous device ("spacer") | Procedure: Spacer Implantation of a percutaneously implanted interspinous device (spacer) |
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 |
Eligibility Criteria
Ages Eligible for Study | 50 Years To 50 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
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 |
Outcome
Primary Outcome Measures
1. Changes in subscores for bodily pain and physical function on SF-36 [baseline, 6 months]
Secondary Outcome Measures
1. Symptoms severity by applying the Zurich Claudication Questionaire (ZCQ) [baseline, 6 months]
2. Physical function by applying ZCQ [baseline, 6 months]
3. Post-treatment patient satisfaction by applying ZCQ [baseline, 6 months]
4. General health status (Quality of life) by applying SF-36 [baseline, 6 months]
5. Measurement of walking distance [baseline, 6 months]