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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01601054
Other study ID # H-2-2012-003
Secondary ID
Status Completed
Phase N/A
First received May 14, 2012
Last updated April 17, 2016
Start date May 2012
Est. completion date December 2015

Study information

Verified date April 2016
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Commite
Study type Interventional

Clinical Trial 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%.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years or more of age

- planned posterior instrumented fusion from thoracic spine to sacrum and/or ilium

Exclusion Criteria:

- malignancy

- infection

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Device:
Tantalum cage from Zimmer
A tantalum cage will be inserted through a left sided retroperitoneal approach

Locations

Country Name City State
Denmark Spine Unit, Rigshospitalet, 9 Blegdamsvej Copenhagen Osterbro

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Revision Surgical revision rate because of implant failure or pseudarthrosis within 12 months after primary procedure 12 months No
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