Health TrialsbyHealthPanel

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

ConditionsDegenerative Lumbar Spinal StenosisFacet Joint ArthrosisSpondylarthritisDiscopathyDegenerative SpondylolisthesisInstability Lumbar Spine
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SpineShape System IV straight rod elastic

    Device

    Implantation of SpineShape System IV straight rod elastic

  • SpineShape System IV straight rod medium

    Device

    Implantation of SpineShape System IV straight rod medium (mid-flex)

  • SpineShape System IV straight rod stiff

    Device

    Implantation of SpineShape System IV straight rod stiff (low-flex)

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: SpineShape System IV straight rod elasticExperimental treatment 1 intervention
Group B: SpineShape System IV straight rod mediumExperimental treatment 1 intervention
Group C: SpineShape System IV straight rod stiffActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analogue Scale (VAS) lower back pain

self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"

Time frame
24 months post-implantation

Secondary outcomes

1

Visual Analogue Scale (VAS) leg pain

self reported leg pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"

Time frame
3, 12, 24, 60 months post-implantation
2

walking duration

self reported walking duration in 5 categories (0-5 min, 6-15 min, 16-30 min, 31-60 min and \>60min)

Time frame
3, 12, 24, 60 months post-implantation
3

medication consumption

use of none, mild pain medication, non-steroidal anti-inflammatory drugs, opioids, and/or antidepressiva documented in patient's health records

Time frame
3, 12, 24, 60 months post-implantation
4

adverse events

adverse events related to the device (e.g. screw loosening, screw breakage, torn rod, slipped rod or too short rod)

Time frame
after 3, 12, 24, 60 months post-implantation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SpineSave AG

Lead sponsor

Source ClinicalTrials.gov
Apply now