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Efficacy of Hybrid Systems in Comparison to the Rigid Spondylodesis in Lumbar-spine Fusion (D-Rod)

This study has been terminated.
(device failure)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01852526
First Posted: May 13, 2013
Last Update Posted: September 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Jan Siewe, University of Cologne
  Purpose

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.


Condition Intervention
Spondylolisthesis Device: Experimental: hybrid system Device: Active Comparator: Plif

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial (Phase II, Therapeutic Explorative) of the Efficacy of Hybrid Systems in Comparison to the Rigid Spondylodesis in Fusion-surgery in the Lumbar Spine: a Prospective, Randomised, Monocenter Pilotstudy

Further study details as provided by Dr. Jan Siewe, University of Cologne:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 6 month ]
    ODI (cross-cultural adaption of the ODI version 2.1 for use with German-speaking patients) - this is one of the condition-specific questionnaires recommended for use with back pain patients. The ODI is a standardized, patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living for those rehabilitating from low back pain. The questionnaire examines perceived level of disability in 10 everyday activities of daily living


Secondary Outcome Measures:
  • SF-36 [ Time Frame: 6 weeks and 6 ,12,24,36 months ]

    The baseline and follow-up values after 6 weeks after the operation as well as 6 ,12,24,36 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).

    The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS).


  • Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36 [ Time Frame: 6 weeks,6, 12,24 and 36 months after baseline ]
    Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 follow-up values after 6 weeks after the operation as well as 6, 12,24 and 36 months after baseline

  • COMI questionnaire (version 2008)- [ Time Frame: 6 weeks, 6, 12, 24, 36 month after baseline ]
    COMI questionnaire (version 2008)- a patient-oriented, short, multidimensional outcome instrument validated for patients with spinal disorders


Enrollment: 5
Study Start Date: March 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hybrid system
hybrid system (PLIF + flexible pedicle screw system above the fusion) (Dynamic Rod®: AESCULAP AG, Tuttlingen: Germany
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
Other Name: D-Rod
Device: Active Comparator: Plif
monosegmental PLIF
Other Name: S4® AESCULAP AG, Cage: Wave® Cage, Fa. AMT®
Active Comparator: Plif posterior lumbar intervertebral fusion
Conventional monosegmental posterior lumbar intervertebral fusion (PLIF) (Fixateur: S4®: AESCULAP AG, Cage: Wave® Cage, Fa. AMT®)
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
Other Name: D-Rod
Device: Active Comparator: Plif
monosegmental PLIF
Other Name: S4® AESCULAP AG, Cage: Wave® Cage, Fa. AMT®

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key- Inclusion Criteria:

  1. Male or female >30 years of age
  2. Lumbar spine pathology with indication for monosegmental PLIF
  3. Radiological signs of a degeneration of the adjacent segment without instability

Key Exclusion Criteria:

  1. Radiological signs of existing instability of the adjacent segment
  2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment
  3. Previous surgery of the lumbar spine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852526


Locations
Germany
University hospital, Department of orthopedics & traumasurgery
Cologne, NRW, Germany, 50924
University hospital, Department of orthopedics
Halle, Sachsen-Anhalt, Germany, 06112
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Jan Siewe, Dr. University Hospital of Cologne
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Jan Siewe, Dr.med., University of Cologne
ClinicalTrials.gov Identifier: NCT01852526     History of Changes
Other Study ID Numbers: Uni-Koeln-1510
AAG-I-H-1110 ( Other Grant/Funding Number: Aeskulap )
First Submitted: May 8, 2013
First Posted: May 13, 2013
Last Update Posted: September 16, 2015
Last Verified: September 2015

Keywords provided by Dr. Jan Siewe, University of Cologne:
degenerative disc disease
spondylolisthesis
Lumbar spine
fusion
adjacent instability

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases