Degenerative Lumbar Spinal StenosisNCT06320899
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
A study testing SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium and SpineShape System IV straight rod stiff in people with Degenerative Lumbar Spinal Stenosis and Facet Joint Arthrosis, run by SpineSave AG at 2 sites in Switzerland.
Trial summary
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis
- What is being tested?
- SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium and SpineShape System IV straight rod stiff
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 4 Jun 2024to 31 Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1
- signed informed consent of participant
- confirmation of the participant that the attendance of follow-up visits are intended
- Body-Mass-Index < 32
- Pedicle screw axis distance < 30mm
- one or more of the following indications:
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- (dynamic) stenosis in the spinal canal
- neuroforaminal stenosis
- facet joint syndrome / spondylarthrosis
- discopathy (recurrent disc hernia)
- degenerative spondylolisthesis (Meyerding <1)
- instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)
Who cannot join
- missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible
- damaged structural tissue, e.g. due to a bone fracture
- application to the thoracic or cervical spine
- pronounced idiopathic scoliosis
- spondylolisthesis > Meyerding grad 1
- isthmic spondolylysis
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- bone tumor
- osteochondrosis modic type I, II or III
- osteoporosis, which could impair screw anchoring
- history with third party implants
- patients with an active local or systemic infection
- known allergy to titatnium alloys
- skeleton in growth (epiphyseal joints not closed)
- severe muscular neuronal or vascular disease
- immunosuppresive therapy
- long-term therapy with cortisone
- heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics
- chronic pain patients
- incapable of judgment or emergency situation
- implantation during pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Spital Aarberg
Aarberg, 3270
Cathrein, +41323668484, dorsomed@hin.ch
Philipp Cathrein, Dr.
- Recruiting
Hirslanden Klinik Linde
Biel, 2501
Cathrein, +41323668484, dorsomed@hin.ch
Philipp Cathrein, Dr.
About this study
Official title: Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases - a Prospective, Multicenter, Randomized Controlled Non-inferiority Study
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.
The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.
Read the detailed description
Dynamic stabilization systems for the lumbar spine are no novelty. The SpineShape System IV builds on the experience of previous systems and attempts to provide additional benefits primarily through three different and relatively elastic rod stiffnesses. 126 subjects with degenerative symptoms in 1 to 2 segments of the lumbar spine L1 to S1 will be recruited. The participants will be randomized in a 1:1:1 ratio to undergo implantation of either the elastic (experimental product group 1), medium (experimental product group 2) or stiff rod (comparison product group).
The aim of the study is to show that the treatment of degenerative lumbar spine with elastic or medium rod variants is not inferior to treatment with hard rods in terms of clinical and safety-related results. This is checked by completing a questionnaire before the surgical procedure and 3 months, 12 months, 24 months and 60 months after the surgical procedure.
- Conditions
- Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis, Discopathy, Degenerative Spondylolisthesis, Instability Lumbar Spine
- Being tested
- SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium, SpineShape System IV straight rod stiff
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpineShape System IV straight rod elasticDevice
Implantation of SpineShape System IV straight rod elastic
SpineShape System IV straight rod mediumDevice
Implantation of SpineShape System IV straight rod medium (mid-flex)
SpineShape System IV straight rod stiffDevice
Implantation of SpineShape System IV straight rod stiff (low-flex)
| Study group | Role | What they receive |
|---|---|---|
| SpineShape System IV straight rod elastic | Experimental | Dynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex) Receives: Device: SpineShape System IV straight rod elastic |
| SpineShape System IV straight rod medium | Experimental | Dynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex) Receives: Device: SpineShape System IV straight rod medium |
| SpineShape System IV straight rod stiff | Active comparator | Dynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex) Receives: Device: SpineShape System IV straight rod stiff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) lower back pain
self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
Measured: 24 months post-implantation
Secondary outcomes (6)
Visual Analogue Scale (VAS) leg pain
self reported leg pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
Measured: 3, 12, 24, 60 months post-implantation
walking duration
self reported walking duration in 5 categories (0-5 min, 6-15 min, 16-30 min, 31-60 min and >60min)
Measured: 3, 12, 24, 60 months post-implantation
medication consumption
use of none, mild pain medication, non-steroidal anti-inflammatory drugs, opioids, and/or antidepressiva documented in patient's health records
Measured: 3, 12, 24, 60 months post-implantation
adverse events
adverse events related to the device (e.g. screw loosening, screw breakage, torn rod, slipped rod or too short rod)
Measured: after 3, 12, 24, 60 months post-implantation
segmental mobility index level
measuring the segmental mobility at index level to verify the preservation of the mobility. an average mobility per segment of >1° is considered a success
Measured: 3, 12, 24, 60 months post-implantation
ability to work/ activity (for retirees)
self reported ability to work or activity (for retirees) in 5 categories (0%, 25%, 50%, 75%, 100%)
Measured: 3, 12, 24, 60 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start4 Jun 2024
- Primary completion31 Aug 2031 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar 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
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SpineSave AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philipp Cathrein, Dr.med., Principal investigator, Hirslanden Klinik Linde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320899
- Sponsor's protocol ID
- SpineShape_CH_001
- Other IDs
- BASEC 2023-D0092
- Status last verified
- Jun 2024
- First submitted
- 13 Mar 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases - a Prospective, Multicenter, Randomized Controlled Non-inferiority Study
- ClinicalTrials.gov ID
- NCT06320899
- Acronym / sponsor ID
- SpineShape_CH_001
- Conditions
- Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis, Discopathy, Degenerative Spondylolisthesis, Instability Lumbar Spine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- SpineSave AGIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 31 Aug 2031 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 20 Mar 2024 (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 purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and safety-related results.
The primary aim is to compare the reduction in back pain after the treatment with high- or mid-flex rods with that after treatment with low-flex rods. Secondary, the functionality after treatment with high- or mid-flex rods will be compared to that after treatment with low-flex rods.
Detailed description
Dynamic stabilization systems for the lumbar spine are no novelty. The SpineShape System IV builds on the experience of previous systems and attempts to provide additional benefits primarily through three different and relatively elastic rod stiffnesses. 126 subjects with degenerative symptoms in 1 to 2 segments of the lumbar spine L1 to S1 will be recruited. The participants will be randomized in a 1:1:1 ratio to undergo implantation of either the elastic (experimental product group 1), medium (experimental product group 2) or stiff rod (comparison product group).
The aim of the study is to show that the treatment of degenerative lumbar spine with elastic or medium rod variants is not inferior to treatment with hard rods in terms of clinical and safety-related results. This is checked by completing a questionnaire before the surgical procedure and 3 months, 12 months, 24 months and 60 months after the surgical procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SpineShape System IV straight rod elastic | Experimental | Device: SpineShape System IV straight rod elasticDynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex) |
| SpineShape System IV straight rod medium | Experimental | Device: SpineShape System IV straight rod mediumDynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex) |
| SpineShape System IV straight rod stiff | Active comparator | Device: SpineShape System IV straight rod stiffDynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- degenerative symptoms in 1 to 2 segments in the lumbar spine L1-S1
- signed informed consent of participant
- confirmation of the participant that the attendance of follow-up visits are intended
- Body-Mass-Index < 32
- Pedicle screw axis distance < 30mm
Key exclusion criteria (20 listed)
- missing bone structure, e.g. due to congenital anomalies or sever anatomical deformities that make anchoring of the implant impossible
- damaged structural tissue, e.g. due to a bone fracture
- application to the thoracic or cervical spine
- pronounced idiopathic scoliosis
- spondylolisthesis > Meyerding grad 1
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 |
|---|---|---|
| SpineShape System IV straight rod elasticImplantation of SpineShape System IV straight rod elastic | Device | SpineShape System IV straight rod elastic |
| SpineShape System IV straight rod mediumImplantation of SpineShape System IV straight rod medium (mid-flex) | Device | SpineShape System IV straight rod medium |
| SpineShape System IV straight rod stiffImplantation of SpineShape System IV straight rod stiff (low-flex) | Device | SpineShape System IV straight rod stiff |
Primary outcome
Visual Analogue Scale (VAS) lower back pain
Time frame: 24 months post-implantation
self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
6 secondary outcomes
Visual Analogue Scale (VAS) leg pain
Time frame: 3, 12, 24, 60 months post-implantation
walking duration
Time frame: 3, 12, 24, 60 months post-implantation
medication consumption
Time frame: 3, 12, 24, 60 months post-implantation
adverse events
Time frame: after 3, 12, 24, 60 months post-implantation
segmental mobility index level
Time frame: 3, 12, 24, 60 months post-implantation
ability to work/ activity (for retirees)
Time frame: 3, 12, 24, 60 months post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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.
Philipp Cathrein, Dr.med. principal investigator
Hirslanden Klinik Linde
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium and SpineShape System IV straight rod stiff in people with Degenerative Lumbar Spinal Stenosis and Facet Joint Arthrosis, run by SpineSave AG at 2 sites in Switzerland.
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 12 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Abramovic (+41448669280, sarah.abramovic@spinesave.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) lower back pain (time frame: 24 months post-implantation). 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 25 Jun 2024.