Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
- Conditions
- Degenerative SpondylolisthesisFacet Joint ArthrosisSpondylarthritisDiscopathyInstability Lumbar SpineDegenerative Lumbar Spinal Stenosis
- Interventions
- Device: SpineShape System IV straight rod stiffDevice: SpineShape System IV straight rod elasticDevice: SpineShape System IV straight rod medium
- Registration Number
- NCT06320899
- Lead Sponsor
- SpineSave AG
- Brief 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.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
-
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:
- (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)
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SpineShape System IV straight rod stiff SpineShape System IV straight rod stiff Dynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex) SpineShape System IV straight rod elastic SpineShape System IV straight rod elastic Dynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex) SpineShape System IV straight rod medium SpineShape System IV straight rod medium Dynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex)
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) lower back pain 24 months post-implantation self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
- Secondary Outcome Measures
Name Time Method segmental mobility index level 3, 12, 24, 60 months post-implantation 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
medication consumption 3, 12, 24, 60 months post-implantation use of none, mild pain medication, non-steroidal anti-inflammatory drugs, opioids, and/or antidepressiva documented in patient's health records
Visual Analogue Scale (VAS) leg pain 3, 12, 24, 60 months post-implantation self reported leg pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
walking duration 3, 12, 24, 60 months post-implantation self reported walking duration in 5 categories (0-5 min, 6-15 min, 16-30 min, 31-60 min and \>60min)
adverse events after 3, 12, 24, 60 months post-implantation adverse events related to the device (e.g. screw loosening, screw breakage, torn rod, slipped rod or too short rod)
ability to work/ activity (for retirees) 3, 12, 24, 60 months post-implantation self reported ability to work or activity (for retirees) in 5 categories (0%, 25%, 50%, 75%, 100%)
Trial Locations
- Locations (2)
Spital Aarberg
🇨🇭Aarberg, Switzerland
Hirslanden Klinik Linde
🇨🇭Biel, Switzerland