NCT01601054

Brief Summary

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

3.6 years

First QC Date

May 14, 2012

Last Update Submit

April 17, 2016

Conditions

Spinal Deformity

Keywords

spinedeformityinstrumentationALIF

Outcome Measures

Primary Outcomes (1)

  • Revision

    Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure

    12 months

Study Arms (2)

Anterior lumbar interbody fusion

ACTIVE COMPARATOR

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

Device: Tantalum cage from Zimmer

Posterior instrumentation alone

ACTIVE COMPARATOR

Posterior pedicle screw instrumentation

Device: Tantalum cage from Zimmer

Interventions

Tantalum cage from ZimmerDEVICE

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

Also known as: Tantalum
Anterior lumbar interbody fusionPosterior instrumentation alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • malignancy
  • infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spine Unit, Rigshospitalet, 9 Blegdamsvej

Copenhagen, Osterbro, 2100, Denmark

Location

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Surgical Instruments

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Benny Dahl, MD

    University of Copenhagen, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Spine Surgery

Study Record Dates

First Submitted

May 14, 2012

First Posted

May 17, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

DK(1)