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A Study Comparing the Outcome of Anterior Lumbar Fusion and Total Lumbar Disc Replacement

NCT ID: NCT03674190

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2022-10-31

Brief Summary

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Total lumbar disc replacement has previously been compared to posterior fusion of the lumbar spine, showing some favor towards total disc replacement. The study aims to compare total disc replacement to anterior fusion, sparing the muscles of the back and thus comparing the two different methods using the same surgical approach.

Detailed Description

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A total of 170 patients are planned to be enrolled in the study. If the patients meet the inclusion criteria and accept to participate they will be randomized to either anterior lumbar fusion or total disc replacement. The method of choice will be blinded for the patients until the two year follow up is completed.

Follow-up: after one and two years. Questionnairs: ODI, VAS, EuroQol, and GA Flexion- Extension X-ray after one and two years Complications will be retrieved from the patient journals.

Conditions

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Disc Disease Degenerative Disk Degeneration Disc Disease Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Anterior Lumbar Interbody Fusion

Surgical treatment Anterior Lumbar Interbody Fusion

Group Type EXPERIMENTAL

Anterior Lumbar Interbody Fusion

Intervention Type PROCEDURE

Anterior Lumbar Fusion(ALIF)

Total disc replacement

Surgical treatment total disc replacement in the lumbar spine

Group Type ACTIVE_COMPARATOR

Total Disc Replacement

Intervention Type PROCEDURE

Total Disc Replacement

Interventions

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Anterior Lumbar Interbody Fusion

Anterior Lumbar Fusion(ALIF)

Intervention Type PROCEDURE

Total Disc Replacement

Total Disc Replacement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with disabling pain from degenerative disc disease(DDD) both clinical and radiological, in one or two segments of the lumbar spine from L4-S1, were prolonged conservative treatment has failed.
* The patient should be able to understand swedish written and spoken.
* The patient should be between the ages 18-65. The patient has to accept to participate in the study

Exclusion Criteria

* More than two degenerated segments.
* Degeneration above the L4 segment.
* Did not agree to participate in the study
* Previous history of tumor, vertebral fracture, infection, lumbar fusion and dominating leg pain.
* Need for posterior decompression
* Pregnancy
* Psychiatric illness or drug abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yara Asterfjord

UNKNOWN

Sponsor Role collaborator

Svante Berg

OTHER

Sponsor Role lead

Responsible Party

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Svante Berg

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Svante Berg, MD, PhD

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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Spine Center Göteborg

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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MollyMoa

Identifier Type: -

Identifier Source: org_study_id