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

June 21, 2024 updated by: SpineSave AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Switzerland
      • Aarberg, Switzerland, 3270
        • Recruiting
        • Spital Aarberg
        • Contact:
        • Principal Investigator:
          • Philipp Cathrein, Dr.
      • Biel, Switzerland, 2501
        • Recruiting
        • Hirslanden Klinik Linde
        • Contact:
        • Principal Investigator:
          • Philipp Cathrein, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SpineShape System IV straight rod elastic
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod elastic (high-flex)
Device: SpineShape System IV straight rod elastic
Implantation of SpineShape System IV straight rod elastic
Experimental: SpineShape System IV straight rod medium
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod medium (mid-flex)
Device: SpineShape System IV straight rod medium
Implantation of SpineShape System IV straight rod medium (mid-flex)
Active Comparator: SpineShape System IV straight rod stiff
Dynamic stabilization of lumbar segments using SpineShape System IV straight rod stiff (low-flex)
Device: SpineShape System IV straight rod stiff
Implantation of SpineShape System IV straight rod stiff (low-flex)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) lower back pain
Time Frame: 24 months post-implantation
self reported back pain intensity using Visual Analogue Scale system. 0 "no pain" to 10 "worst possible pain"
24 months post-implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
walking duration
Time Frame: 3, 12, 24, 60 months post-implantation
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
medication consumption
Time Frame: 3, 12, 24, 60 months post-implantation
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
adverse events
Time Frame: after 3, 12, 24, 60 months post-implantation
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
segmental mobility index level
Time Frame: 3, 12, 24, 60 months post-implantation
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
ability to work/ activity (for retirees)
Time Frame: 3, 12, 24, 60 months post-implantation
self reported ability to work or activity (for retirees) in 5 categories (0%, 25%, 50%, 75%, 100%)
3, 12, 24, 60 months post-implantation
Visual Analogue Scale (VAS) leg pain
Time Frame: 3, 12, 24, 60 months post-implantation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SpineSave AG

Investigators

  • Principal Investigator: Philipp Cathrein, Dr.med., Hirslanden Klinik Linde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2024

Primary Completion (Estimated)

August 31, 2031

Study Completion (Estimated)

August 31, 2031

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SpineShape_CH_001
  • BASEC 2023-D0092 (Other Identifier: Ethics Committee Bern)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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