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A Comparative Study Between Mechanical and a Viscoelastic Disc Prosthesis in the Lumbar Spine

NCT ID: NCT03716947

Last Updated: 2020-12-16

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2022-12-31

Brief Summary

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TDR implants for the lumbar spine are currently most 2- or 3-piece devices with a purely mechanical function that provide/restore mobility. Lately interest is growing on non-mechanical implants that could possibly provide/restore mobility, but also produce counterforces on mobility as in healthy discs. No previous comparison between these two concepts has been performed, neither on clinical outcome, neither on specific differences on facet-joint load and wear.

Detailed Description

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A total of 250 patients are to be enrolled and treated. Inclusion criteria is unbearable pain and dysfunction from degenerative disc disease (DDD) that at one or two segments in the lover lumbar spine, that has not responded positively from at least one year of conservative treatment (that is combination of intense physical training and drugs).

Patients with DDD below L3 vertebra are divided I three groups:

1. One segment DDD appropriate for treatment with TDR.
2. Two segments DDD appropriate for treatment with TDR.
3. One segment DDD appropriate for treatment with TDR and one segment DDD not appropriate for treatment with TDR, that will be treated with anterior fusion (ALIF) at the same surgical procedure, called "hybrids". Within all three groups there will be an equal randomization between the two prosthesis types.

Clinical outcome will be evaluated from questionnaires sent out to patients after 12- and 24 months and 5- and 10 years after surgery. The questionnaire are the currently used ones from the Swedish Spine Registry (SweSpine) including VAS leg/back, EuroQol ,GA and ODI. Complications will be registered continuously and facet-joint load/health will be examined from flex-ext x-rays at 1 and 2 years. At the 2-year check up a 3D-CT will be performed to further evaluate the facet joints and their load under flex-ext.

Conditions

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Degenerative Disc Disease Discogenic Low Back Pain

Keywords

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Clinical outcome Mobility Facet-joints

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ORBIT Mechanical disc prosthesis

Surgical procedure with total disc replacement using mechanical disc prosthesis device, "ORBIT, Globus Medical"

Group Type ACTIVE_COMPARATOR

Device: ZACK

Intervention Type PROCEDURE

Surgical procedure with total disc replacement using ZACK disc prostheses

ZACK viscoelastic disc prosthesis

Surgical procedure with total disc replacement using viscoelastic disc prosthesis device, "ZACK, FH Orthopaedics"

Group Type EXPERIMENTAL

Device: ORBIT

Intervention Type PROCEDURE

Surgical procedure with total disc replacement using ORBIT disc prostheses

ORBIT SASCA

Surgical procedure with total disc replacement (TDR) using ORBIT disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA.

Group Type ACTIVE_COMPARATOR

Device: ZACK

Intervention Type PROCEDURE

Surgical procedure with total disc replacement using ZACK disc prostheses

Device: SASCA

Intervention Type PROCEDURE

Surgical procedure with anterior intracorporal fusion (ALIF) combined with adjacent level total disc replacement (TDR) (using either ORBIT mechanical disc prosthesis or ZACK viscoelastic disc prosthesis)

ZACK SASCA

Surgical procedure with total disc replacement (TDR) using ZACK disc prostheses device combined with adjacent level anterior intracorporal fusion (ALIF) with intracorporal device SASCA.

Group Type EXPERIMENTAL

Device: ORBIT

Intervention Type PROCEDURE

Surgical procedure with total disc replacement using ORBIT disc prostheses

Device: SASCA

Intervention Type PROCEDURE

Surgical procedure with anterior intracorporal fusion (ALIF) combined with adjacent level total disc replacement (TDR) (using either ORBIT mechanical disc prosthesis or ZACK viscoelastic disc prosthesis)

Interventions

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Device: ZACK

Surgical procedure with total disc replacement using ZACK disc prostheses

Intervention Type PROCEDURE

Device: ORBIT

Surgical procedure with total disc replacement using ORBIT disc prostheses

Intervention Type PROCEDURE

Device: SASCA

Surgical procedure with anterior intracorporal fusion (ALIF) combined with adjacent level total disc replacement (TDR) (using either ORBIT mechanical disc prosthesis or ZACK viscoelastic disc prosthesis)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Incapacitating pain from DDD (both clinical and radiological) in one or two segments below the L3 vertebra, were at least one segment is suitable for TDR treatment.
* Patient with more than one year of pain, that has during this period made a prolonged and adequate conservative program.

-Patient between 20 and 55 years of age. -

-Patient able to understand written and spoken Swedish.

Exclusion Criteria

* Patient does not accept to be part of the study.
* Three or more segments suspected to be symptomatic.
* Earlier vertebral fracture, tumour, infection or fusion in the lumbar spine. -Substantial scoliosis/deformity.
* Need for posterior decompression.
* Pregnancy, psychiatric illness or drug abuse. -Patient does not understand written and spoken Swedish and can thus not take part in information and answer questionnaires.

-Patient residing outside Sweden and thus is not covered with SweSpine. -
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Svante Berg

MD, PhD, Associate Professor, Senior Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Svante Berg, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Stockholm Spine Center

Stockholm, Upplands Väsby, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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mojje

Identifier Type: -

Identifier Source: org_study_id