The safety and performance of the Elaspine™ Implant System in the treatment of lower back pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing clinical study (PMCS). The study will be enrolled within Germany and Switzerland in 3-5 clinical centres, including in average 10 patients per centre. The study is conducted in accordance with the Standard ISO 14155, where applicable on clinical investigation of medical devices for human subjects and other legal requirements.
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient has signed and understood the approved Informed Consent form and is able to meet the proposed follow-up and postoperative management program.
. Patient is skeletally mature and between 21 - 80 years of age.
. Patient's pre-operative Body Mass Index (BMI) is ≤ 34.
. Patient's pre-operative Oswestry Disability Index (ODI) is ≥ 30% (≥15 out of 50 points).
. Patient's pre-operative back pain Visual Analogue Scale (VAS) is \>60 (0-100 scale), with or without associated leg pain (leg pain VAS score).
. Patient has received non-operative treatment for low back pain for \> 6 months and is unresponsive.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patient has one or more of the following structural abnormalities with imaging studies verifying them at one or two contiguous levels within L1-L5:
Exclusion criteria
. Degenerative spondylolisthesis greater than Grade 1 as defined by greater than 25 percent vertebral slip forward over the inferior vertebral body (acc. to Meyerding Classification) or significant segmental instability at or adjacent to intended treatment level.
. Need for more than two-level or two non-contiguous-level surgery in the lumbar spine.
. Patient has more than 50% defective facet joint (half of the articular joint surface) or laminectomy
. Patient is scheduled for another lumbar surgery such as but not limited to a fusion
. Patient has recent vertebral fractures or past fractures which did not heal.
. Patient has known allergies to titanium alloy and polycarbonate urethane (PCU).
. Patient has clinically compromised vertebral body structure and morphology at the lumbar spine due to current or past trauma (or pathological vertebral fracture) or significant endplate incompetence such as Schmorl´s node.
. Patient has spondylolysis at the levels to be treated or an adjacent level.