Spinal StenosisSURGIMMONCT05312281
Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.
A study testing Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo in people with Spinal Stenosis, run by SRH Gesundheitszentrum Bad Herrenalb at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)-
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinikum Karlsruhe
Karlsruhe, 76133
Uwe Spetzger, +497219740, uwe.spetzger@klinikum-karlsruhe.de
Andreas Veihelmann, +497083926, andreas.veihelmann@sportklinik-stuttgart.de
About this study
Official title: Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis
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
Read the 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.
- Conditions
- Spinal Stenosis
- Being tested
- Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab ImmoDevice
Wear for 6 weeks post-surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group "without lumbar belt" | No intervention | Control group "without lumbar belt" |
| Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo | Experimental | Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo Receives: Device: Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate or reherniation/restenosis by means of MRI results
symptomatic reduction of Walking distance
Measured: at 104 weeks
Secondary outcomes (1)
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)
Measured: At 0, 2, 6, 12, 24, 52 and 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start28 Jun 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SRH Gesundheitszentrum Bad Herrenalb
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Andreas Veihelmann, Prof, Study chair, SRH Ges.-Zentrum Bad Herrenalb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312281
- Sponsor's protocol ID
- GBH-O1
- Acronym
- SURGIMMO
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis. With and Without Immobilisation in an Orthosis
- ClinicalTrials.gov ID
- NCT05312281
- Acronym / sponsor ID
- SURGIMMO / GBH-O1
- Conditions
- Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SRH Gesundheitszentrum Bad HerrenalbResearch network
- Study start
- 28 Jun 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group "without lumbar belt" | No intervention | –Control group "without lumbar belt" |
| Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo | Experimental | Device: Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab ImmoLombastab immo. wear for 6 weeks post-surgery the Lombastab Immo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab ImmoWear for 6 weeks post-surgery | Device | Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo |
Primary outcome
Recurrence rate or reherniation/restenosis by means of MRI results
Time frame: at 104 weeks
symptomatic reduction of Walking distance
1 secondary outcome
Pain and Disability Index
Time frame: At 0, 2, 6, 12, 24, 52 and 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Veihelmann, Prof study chair
SRH Ges.-Zentrum Bad Herrenalb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device : Lombastab immo. wear for 6 weeks post-surgery the Lombastab Immo in people with Spinal Stenosis, run by SRH Gesundheitszentrum Bad Herrenalb at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uwe Spetzger, Prof (+497219740, uwe.spetzger@klinikum-karlsruhe.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate or reherniation/restenosis by means of MRI results (time frame: at 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.