Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. (SURGIMMO)
Primary Purpose
Spinal Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Stenosis
Eligibility Criteria
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)-
Sites / Locations
- Klinikum KarlsruheRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group "without lumbar belt"
Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Arm Description
Control group "without lumbar belt"
Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Outcomes
Primary Outcome Measures
Recurrence rate or reherniation/restenosis by means of MRI results
symptomatic reduction of Walking distance
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT05312281
First Posted
March 10, 2022
Last Updated
March 28, 2022
Sponsor
SRH Gesundheitszentrum Bad Herrenalb
1. Study Identification
Unique Protocol Identification Number
NCT05312281
Brief Title
Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.
Acronym
SURGIMMO
Official Title
Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SRH Gesundheitszentrum Bad Herrenalb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
Spinal stenosis and orthoses The study situation in this regard is very poor, high-quality level 1 studies are not available.
A study by Prateepavanich et al. from 2001 shows advantages in the therapy with lumbar orthoses in neurogenic spinal claudication in the context of conservative therapy (9). Regarding postoperative prescription, expert opinions have long diverged (10). Nevertheless, in a survey of North American spine surgeons, over 60% reported prescribing an orthosis postoperatively (11).
2 Aim of the study
The aim of this study is to show that patients after surgical decompression for lumbar spinal stenosis and patients after surgical sequestrectomy benefit from temporary postoperative immobilization using a lumbar orthosis.
To show that postoperative therapy with a lumbar orthosis prolongs walking distance and reduces early recurrence.
It will be shown that postoperative pain decreases significantly faster and thus pain medication can be reduced faster early postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group "without lumbar belt"
Arm Type
No Intervention
Arm Description
Control group "without lumbar belt"
Arm Title
Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Arm Type
Experimental
Arm Description
Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Intervention Type
Device
Intervention Name(s)
Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Intervention Description
Wear for 6 weeks post-surgery
Primary Outcome Measure Information:
Title
Recurrence rate or reherniation/restenosis by means of MRI results
Description
symptomatic reduction of Walking distance
Time Frame
at 104 weeks
Secondary Outcome Measure Information:
Title
Pain and Disability Index
Description
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)
Time Frame
At 0, 2, 6, 12, 24, 52 and 104 weeks
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uwe Spetzger, Prof
Phone
+497219740
Email
uwe.spetzger@klinikum-karlsruhe.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Veihelmann, Prof
Phone
+497083926
Ext
4023
Email
andreas.veihelmann@sportklinik-stuttgart.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Veihelmann, Prof
Organizational Affiliation
SRH Ges.-Zentrum Bad Herrenalb
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uwe Spetzger
Phone
+497219740
Email
uwe.spetzger@klinikum-karlsruhe.de
First Name & Middle Initial & Last Name & Degree
Andreas Veihelmann
Phone
+497083926
Email
andreas.veihelmann@sportklinik-stuttgart.de
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.
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