Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Recruiting
N/A
Interventional Study
Degenerative Lumbar Spinal Stenosis
Facet Joint Arthrosis
Spondylarthritis
Discopathy
Degenerative Spondylolisthesis
Instability Lumbar Spine
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 126 (estimated)
- Sponsor
- SpineSave AG · Industry
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About This Trial
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.…
Trial Locations
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Eligibility 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…
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