Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
2 other identifiers
interventional
126
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
June 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2031
June 25, 2024
June 1, 2024
7.2 years
March 13, 2024
June 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale (VAS) lower back pain
self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
24 months post-implantation
Secondary Outcomes (6)
Visual Analogue Scale (VAS) leg pain
3, 12, 24, 60 months post-implantation
walking duration
3, 12, 24, 60 months post-implantation
medication consumption
3, 12, 24, 60 months post-implantation
adverse events
after 3, 12, 24, 60 months post-implantation
segmental mobility index level
3, 12, 24, 60 months post-implantation
- +1 more secondary outcomes
Study Arms (3)
SpineShape System IV straight rod elastic
EXPERIMENTALDynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex)
SpineShape System IV straight rod medium
EXPERIMENTALDynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex)
SpineShape System IV straight rod stiff
ACTIVE COMPARATORDynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex)
Interventions
Implantation of SpineShape System IV straight rod elastic
Implantation of SpineShape System IV straight rod medium (mid-flex)
Implantation of SpineShape System IV straight rod stiff (low-flex)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SpineSave AGlead
Study Sites (2)
Spital Aarberg
Aarberg, 3270, Switzerland
Hirslanden Klinik Linde
Biel, 2501, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Cathrein, Dr.med.
Hirslanden Klinik Linde
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2024
First Posted
March 20, 2024
Study Start
June 4, 2024
Primary Completion (Estimated)
August 31, 2031
Study Completion (Estimated)
August 31, 2031
Last Updated
June 25, 2024
Record last verified: 2024-06