Actively Recruiting
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
Led by SpineSave AG · Updated on 2024-06-25
126
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare different types of rods used in the surgical treatment of degenerative lumbar spine diseases. The study focuses on patients with degenerative symptoms in one or two segments of the lumbar spine from L1 to S1. It seeks to determine whether the use of high-flex (elastic) or mid-flex (medium) rods provides clinical and safety outcomes that are not inferior to those achieved with low-flex (stiff) rods, with a special focus on reducing back pain and improving functionality after surgery. Participants will be randomly assigned to receive one of three types of SpineShape System IV rods: elastic (high-flex), medium (mid-flex), or stiff (low-flex). Each group will undergo dynamic stabilization surgery using the assigned rod type. The study will follow patients over five years, with evaluations occurring before surgery and at 3, 12, 24, and 60 months after implantation to assess pain levels, mobility, medication use, and other health indicators. During the study, participants will complete questionnaires and undergo clinical assessments to measure back and leg pain using the Visual Analogue Scale (VAS), walking duration, medication consumption, and segmental mobility. Researchers will also monitor adverse events and participants' ability to work or perform activities. The total participation spans at least five years, with regular follow-up visits to collect data on safety and treatment outcomes.
CONDITIONS
Brief 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...
- Adults with degenerative symptoms in 1 to 2 lumbar spine segments between L1 and S1
- Signed informed consent from the participant
- Participant intends to attend follow-up visits
- Body-Mass-Index less than 32
- Pedicle screw axis distance less than 30 mm
- Diagnosis of one or more 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 with decompression)
You will not qualify if you...
- Missing bone structure due to congenital anomalies or severe deformities preventing implant anchoring
- Damaged structural tissue such as bone fractures
- Application to thoracic or cervical spine instead of lumbar spine
- Pronounced idiopathic scoliosis
- Spondylolisthesis greater than Meyerding grade 1
- Isthmic spondylolysis
- Bone tumors
- Osteochondrosis Modic type I, II, or III
- Osteoporosis that may impair screw anchoring
- History of third party implants
- Active local or systemic infection
- Known allergy to titanium alloys
- Skeletal growth not completed (open epiphyseal joints)
- Severe muscular, neuronal, or vascular diseases
- Use of immunosuppressive therapy
- Long-term cortisone therapy
- Heavy smoking (more than six cigarettes per day), drug addiction, or alcoholism
- Chronic pain conditions
- Incapacity for judgment or emergency situations
- Pregnancy or implantation during pregnancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo implantation of one of the SpineShape System IV rods (elastic, medium, or stiff) for dynamic stabilization of lumbar spine segments.
1 surgical visit (in-person)
Duration - Up to 60 months after surgery
Participants complete questionnaires and assessments regarding pain, mobility, medication use, and activity at multiple time points after surgery.
Visits at 3, 12, 24, and 60 months post-implantation
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
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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