Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative… (NCT06320899) | Clinical Trial Compass
RecruitingNot Applicable
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Switzerland126 participantsStarted 2024-06-04
Plain-language 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.
Who can participate
Age range
18 Years – 99 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:
* 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 p…
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.