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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorSpineSave AG

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SpineShape System IV straight rod elastic
  • SpineShape System IV straight rod medium
  • SpineShape System IV straight rod stiff

Treatment groups

126 Participants
are divided into 3 treatment groups

Sponsors and collaborators