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Efficacy of Hybrid Systems in Comparison to the Rigid Spondylodesis in Lumbar-spine Fusion

NCT01852526 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2015-09-16

No results posted yet for this study

Summary

This study is designed as a randomized, parallel-group, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to our outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After informed consent and randomization of patients, surgery will be performed. Follow-up examinations will take place immediately after treatment during hospital stay, and then after another 6 and 24 weeks, for a total study duration of 6 months. Data will be assessed after 12, 24 and 36 months for a supplemental investigation. A further assessment will be performed every year, owing to the possibility that a statement regarding ASD cannot be given after 36 months.

Experimental research in this trial will be performed with the approval of the ethics committee of the medical faculty of the University of Cologne and of the university of Halle.

Conditions

  • Spondylolisthesis

Interventions

DEVICE

Experimental: hybrid system

The intervention group will receive a hybrid system with PLIF and a flexible pedicle screw system above the fusion. Surgery will be performed using the following devices (Dynamic Rod® Hersteller: AESCULAP AG, Tuttlingen

DEVICE

Active Comparator: Plif

monosegmental PLIF

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Jan Siewe, Dr. · University Hospital of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2017-02-28
Completion
2017-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852526 on ClinicalTrials.gov