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

Degenerative Spondylolisthesis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06320899
• Other study ID #: SpineShape_CH_001
• Secondary ID: BASEC 2023-D0092
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: August 31, 2031

Study information

• Verified date: March 2024
• Source: SpineSave AG
• Contact: Sarah Abramovic
• Phone: +41448669280
• Email: sarah.abramovic[@]spinesave.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Dynamic stabilization systems for the lumbar spine are no novelty. The SpineShape System IV builds on the experience of previous systems and attempts to provide additional benefits primarily through three different and relatively elastic rod stiffnesses. 126 subjects with degenerative symptoms in 1 to 2 segments of the lumbar spine L1 to S1 will be recruited. The participants will be randomized in a 1:1:1 ratio to undergo implantation of either the elastic (experimental product group 1), medium (experimental product group 2) or stiff rod (comparison product group).

The aim of the study is to show that the treatment of degenerative lumbar spine with elastic or medium rod variants is not inferior to treatment with hard rods in terms of clinical and safety-related results. This is checked by completing a questionnaire before the surgical procedure and 3 months, 12 months, 24 months and 60 months after the surgical procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: August 31, 2031
• Est. primary completion date: August 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

• Pedicle screw axis distance < 30mm

• one or more of the following indications:

• (dynamic) stenosis in the spinal canal

• neuroforaminal stenosis

• facet joint syndrome / spondylarthrosis

• discopathy (recurrent disc hernia)

• degenerative spondylolisthesis (Meyerding <1)

• instability (hypermobility with antelishtesis, hypomobility with retrolisthesis if decompressed)

Exclusion Criteria:

• 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

• spondylolisthesis > Meyerding grad 1

• isthmic spondolylysis

• bone tumor

• osteochondrosis modic type I, II or III

• osteoporosis, which could impair screw anchoring

• history with third party implants

• patients with an active local or systemic infection

• known allergy to titatnium alloys

• skeleton in growth (epiphyseal joints not closed)

• severe muscular neuronal or vascular disease

• immunosuppresive therapy

• long-term therapy with cortisone

• heavy smokers (regular consumption of more than six cigarettes per day), drug addicts and alcoholics

• chronic pain patients

• incapable of judgment or emergency situation

• implantation during pregnancy

Related Conditions & MeSH terms

• Degenerative Lumbar Spinal Stenosis
• Degenerative Spondylolisthesis
• Discopathy
• Instability Lumbar Spine
• Osteoarthritis
• Spinal Diseases
• Spinal Stenosis
• Spondylarthritis
• Spondylitis
• Spondylolisthesis

Intervention

Device:
• SpineShape System IV straight rod elastic
Implantation of SpineShape System IV straight rod elastic
• SpineShape System IV straight rod medium
Implantation of SpineShape System IV straight rod medium (mid-flex)
• SpineShape System IV straight rod stiff
Implantation of SpineShape System IV straight rod stiff (low-flex)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SpineSave AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS Score lower back pain	self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"	24 months post-implantation
Secondary	VAS Score leg pain	self reported leg pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"	3, 12, 24, 60 months post-implantation
Secondary	walking duration	self reported walking duration in 5 categories (0-5 min, 6-15 min, 16-30 min, 31-60 min and >60min)	3, 12, 24, 60 months post-implantation
Secondary	medication consumption	use of none, mild pain medication, non-steroidal anti-inflammatory drugs, opioids, and/or antidepressiva documented in patient's health records	3, 12, 24, 60 months post-implantation
Secondary	adverse events	adverse events related to the device (e.g. screw loosening, screw breakage, torn rod, slipped rod or too short rod)	after 3, 12, 24, 60 months post-implantation
Secondary	segmental mobility index level	measuring the segmental mobility at index level to verify the preservation of the mobility. an average mobility per segment of >1° is considered a success	3, 12, 24, 60 months post-implantation
Secondary	ability to work/ activity (for retirees)	self reported ability to work or activity (for retirees) in 5 categories (0%, 25%, 50%, 75%, 100%)	3, 12, 24, 60 months post-implantation