Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity

NCT ID: NCT01601054

Last Updated: 2016-04-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-12-31

Brief Summary

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Within the last decade there has been an increase in the number of surgical procedures for deformities of the spine. This is caused by the increase in the elderly population, improved surgical techniques and an increased number of patients who have undergone previous surgical treatment for degenerative conditions of the spine. Surgical treatment of spinal deformities bears a revision rate between 15 and 30% depending on definition, and one of the primary reasons for revision surgery is implant loosening in the lumbosacral region.

The hypothesis of the study is that a procedure resulting in anterior fusion of the lumbar spine in addition to the usual posterior instrumentation can reduce the revision rate with 50%.

Detailed Description

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Conditions

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Spinal Deformity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Anterior lumbar interbody fusion

Anterior lumbar interbody fusion using a tantalum cage. Cage will be inserted through a left sided retroperitoneal approach.

Group Type ACTIVE_COMPARATOR

Tantalum cage from Zimmer

Intervention Type DEVICE

A tantalum cage will be inserted through a left sided retroperitoneal approach

Posterior instrumentation alone

Posterior pedicle screw instrumentation

Group Type ACTIVE_COMPARATOR

Tantalum cage from Zimmer

Intervention Type DEVICE

A tantalum cage will be inserted through a left sided retroperitoneal approach

Interventions

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Tantalum cage from Zimmer

A tantalum cage will be inserted through a left sided retroperitoneal approach

Intervention Type DEVICE

Other Intervention Names

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Tantalum

Eligibility Criteria

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Inclusion Criteria

* 18 years or more of age
* planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium

Exclusion Criteria

* malignancy
* infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Benny Dahl, MD, PhD

Professor of Spine Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benny Dahl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, Rigshospitalet

Locations

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Spine Unit, Rigshospitalet, 9 Blegdamsvej

Copenhagen, Osterbro, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2012-003

Identifier Type: -

Identifier Source: org_study_id

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