Comparing different flexibility rods for treating degenerative lumbar spine diseases
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
This study is testing whether different types of flexibility rods can help people with degenerative lumbar spine issues feel less back pain and improve their functionality over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | SpineSave AG Industry-sponsored |
| Locations | 2 sites (Aarberg and 1 other locations) |
| Trial ID | NCT06320899 on ClinicalTrials.gov |
What this trial studies
This multi-center, randomized clinical study aims to evaluate the effectiveness and safety of high- or mid-flex rods compared to low-flex rods in treating degenerative lumbar spine conditions. A total of 126 participants with degenerative symptoms affecting 1 to 2 segments of the lumbar spine will be recruited and randomly assigned to receive one of three types of rods: elastic, medium, or stiff. The primary outcome will be the reduction in back pain, while secondary outcomes will assess functionality over a period of up to five years through follow-up questionnaires.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals experiencing degenerative symptoms in 1 to 2 segments of the lumbar spine, specifically between L1 and S1.
Not a fit: Patients with severe anatomical deformities or conditions that prevent the anchoring of the implant, or those with advanced spondylolisthesis, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective treatment option for degenerative lumbar spine diseases, potentially leading to better pain management and improved functionality.
How similar studies have performed: While dynamic stabilization systems are not new, this specific comparison of rod flexibility in treating lumbar spine diseases is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Aarberg and 1 other locations
- Spital Aarberg — Aarberg, Switzerland (Recruiting)
- Hirslanden Klinik Linde — Biel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Philipp Cathrein, Dr.med. — Hirslanden Klinik Linde
- Study coordinator: Sarah Abramovic
- Email: sarah.abramovic@spinesave.com
- Phone: +41448669280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.