Actively Recruiting
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Led by SpineSave AG · Updated on 2024-06-25
126
Participants Needed
2
Research Sites
377 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Degenerative symptoms in 1 to 2 lumbar spine segments from L1 to S1
- Signed informed consent from participant
- Participant agrees to attend follow-up visits
- Body-Mass-Index less than 32
- Pedicle screw axis distance less than 30 mm
- Presence of at least one of the following: dynamic spinal canal stenosis, neuroforaminal stenosis, facet joint syndrome or spondylarthrosis, discopathy including recurrent disc hernia, degenerative spondylolisthesis (Meyerding grade less than 1), or lumbar spine instability (hypermobility or hypomobility if decompressed)
You will not qualify if you...
- Missing bone structure due to congenital anomalies or severe anatomical deformities preventing implant anchoring
- Damaged structural tissue such as from a bone fracture
- Condition affecting the thoracic or cervical spine
- Pronounced idiopathic scoliosis
- Spondylolisthesis with Meyerding grade greater than 1
- Isthmic spondylolysis
- Bone tumor
- Osteochondrosis Modic type I, II, or III
- Osteoporosis impairing screw anchoring
- History of third-party implants
- Active local or systemic infection
- Known allergy to titanium alloys
- Growing skeleton with open epiphyseal joints
- Severe muscular, neuronal, or vascular disease
- Immunosuppressive therapy
- Long-term cortisone therapy
- Heavy smoking (more than six cigarettes daily), drug addiction, or alcoholism
- Chronic pain conditions
- Incapable of judgment or emergency situations
- Implantation during pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Spital Aarberg
Aarberg, Switzerland, 3270
Actively Recruiting
2
Hirslanden Klinik Linde
Biel, Switzerland, 2501
Actively Recruiting
Research Team
S
Sarah Abramovic
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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