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RECRUITING
NCT06320899
NA

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

Sponsor: SpineSave AG

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2024-06-04

Completion Date

2031-08-31

Last Updated

2024-06-25

Healthy Volunteers

No

Interventions

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)

Locations (2)

Spital Aarberg

Aarberg, Switzerland

Hirslanden Klinik Linde

Biel, Switzerland