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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-04

Study Completion Date

2031-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SpineShape System IV straight rod elastic

Dynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex)

Group Type EXPERIMENTAL

SpineShape System IV straight rod elastic

Intervention Type DEVICE

Implantation of SpineShape System IV straight rod elastic

SpineShape System IV straight rod medium

Dynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex)

Group Type EXPERIMENTAL

SpineShape System IV straight rod medium

Intervention Type DEVICE

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

SpineShape System IV straight rod stiff

Dynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex)

Group Type ACTIVE_COMPARATOR

SpineShape System IV straight rod stiff

Intervention Type DEVICE

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

Interventions

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SpineShape System IV straight rod elastic

Implantation of SpineShape System IV straight rod elastic

Intervention Type DEVICE

SpineShape System IV straight rod medium

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

Intervention Type DEVICE

SpineShape System IV straight rod stiff

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No