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

NARecruitingINTERVENTIONAL
Enrollment

126

Participants

Timeline

Start Date

June 4, 2024

Primary Completion Date

August 31, 2031

Study Completion Date

August 31, 2031

Conditions
Degenerative Lumbar Spinal StenosisFacet Joint ArthrosisSpondylarthritisDiscopathyDegenerative SpondylolisthesisInstability 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)

Trial Locations (2)

2501

RECRUITING

Hirslanden Klinik Linde, Biel

3270

RECRUITING

Spital Aarberg, Aarberg

All Listed Sponsors
lead

SpineSave AG

INDUSTRY