MedTrace Logo

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

NCT06320899 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-06-25

No results posted yet for this study

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.

Conditions

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

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)

Sponsors & Collaborators

  • SpineSave AG

    lead INDUSTRY

Principal Investigators

  • Philipp Cathrein, Dr.med. · Hirslanden Klinik Linde

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2031-08-31
Completion
2031-08-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06320899 on ClinicalTrials.gov