Spinal Stenosis Clinical Trial
— SURGIMMOOfficial title:
Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis
NCT number | NCT05312281 |
Other study ID # | GBH-O1 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 28, 2022 |
Est. completion date | December 1, 2025 |
The aim of the study is to assess the benefit of wearing a lumbar orthosis after surgery for spinal stenosis. It will be evaluated if a post-surgery immobilization for 6 weeks with a lumbar orthosis reduces early recurrence, increases walking distance, decreases significantly faster pain and pain medication after surgery
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy. Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis. - Age 20-80 years - Pre-operative walking distance at least 100m - Consent form signed by the patient Exclusion Criteria: - Fusion surgery or recurrent surgery - Tumors of the spine - Cervical spinal stenosis or myelopathy - Rheumatoid arthritis or similar autoimmune disease - Infection - request for a pension - Dyspnea due to heart failure with limited walking distance - Peripheral Arterial Occlusive Disease (PAOD)- |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Karlsruhe | Karlsruhe |
Lead Sponsor | Collaborator |
---|---|
SRH Gesundheitszentrum Bad Herrenalb |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence rate or reherniation/restenosis by means of MRI results | symptomatic reduction of Walking distance | at 104 weeks | |
Secondary | Pain and Disability Index | Visual analog scale (VAS) (visual analog scale of 0-10, 0 means no pain, 10 means extreme pain, we expect better outcome with Lombastab), Oswestry Disability Questionaire (german version scale of 0-50, 0 means no impairment at all, 50 means highest possible impairment, we expect lower impairment due to Lombastab) | At 0, 2, 6, 12, 24, 52 and 104 weeks |
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