Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.
SURGIMMO
Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedStudy Start
First participant enrolled
June 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedApril 5, 2022
March 1, 2022
2.4 years
March 10, 2022
March 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Recurrence rate or reherniation/restenosis by means of MRI results
symptomatic reduction of Walking distance
at 104 weeks
Secondary Outcomes (1)
Pain and Disability Index
At 0, 2, 6, 12, 24, 52 and 104 weeks
Study Arms (2)
Control group "without lumbar belt"
NO INTERVENTIONControl group "without lumbar belt"
Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
EXPERIMENTALLombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
Interventions
Wear for 6 weeks post-surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Karlsruhe
Karlsruhe, 76133, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andreas Veihelmann, Prof
SRH Ges.-Zentrum Bad Herrenalb
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2022
First Posted
April 5, 2022
Study Start
June 28, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
April 5, 2022
Record last verified: 2022-03