NCT06320899

Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: SpineSave AG · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Dynamic stabilization systems for the lumbar spine are no novelty. The SpineShape System IV builds on the experience of previous systems and attempts to provide additional benefits primarily through three different and relatively elastic rod stiffnesses. 126 subjects with degenerative symptoms in 1 to 2 segments of the lumbar spine L1 to S1 will be recruited. The participants will be randomized in a 1:1:1 ratio to undergo implantation of either the elastic (experimental product group 1), medium (experimental product group 2) or stiff rod (comparison product group). The aim of the study is to show that the treatment of degenerative lumbar spine with elastic or medium rod variants is not inferior to treatment with hard rods in terms of clinical and safety-related results. This is checked by completing a questionnaire before the surgical procedure and 3 months, 12 months, 24 months and 60 months after the surgical procedure.

Conditions

• Degenerative Lumbar Spinal Stenosis
• Facet Joint Arthrosis
• Spondylarthritis
• Discopathy
• Degenerative Spondylolisthesis
• Instability Lumbar Spine

Interventions

Type	Name	Description
DEVICE	SpineShape System IV straight rod elastic	Implantation of SpineShape System IV straight rod elastic
DEVICE	SpineShape System IV straight rod medium	Implantation of SpineShape System IV straight rod medium (mid-flex)
DEVICE	SpineShape System IV straight rod stiff	Implantation of SpineShape System IV straight rod stiff (low-flex)

Timeline

• Start date: 2024-06-04
• Primary completion: 2031-08-31
• Completion: 2031-08-31
• First posted: 2024-03-20
• Last updated: 2024-06-25

Locations

2 sites across 1 country: Switzerland