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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Dr. Jan Siewe, University of Cologne
ClinicalTrials.gov Identifier:
NCT01852526
First received: May 8, 2013
Last updated: April 14, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Cologne:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    COMI questionnaire (version 2008)- a patient-oriented, short, multidimensional outcome instrument validated for patients with spinal disorders


Estimated Enrollment: 40
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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852526

Locations
Germany
University hospital, Department of orthopedics & traumasurgery Not yet recruiting
Cologne, NRW, Germany, 50924
Contact: Jan Siewe, Dr.med.    +49-221-478-87294    studienzentrum-ortho-unfall@uk-koeln.de   
Contact: Margarete Wicharz    +49-221-478-87294    studienzentrum-ortho-unfall@uk-koeln.de   
Principal Investigator: Jan Siewe, Dr. med.         
University hospital, Department of orthopedics Recruiting
Halle, Sachsen-Anhalt, Germany, 06112
Contact: Stefan Delank, Prof.Dr.    +49(0)345 557 4805    orthopaedie@uk-halle.de   
Contact: Marc Röllinghoff, Dr. med.    +49(0)345 557 4805    orthopaedie@uk-halle.de   
Principal Investigator: Stefan Delank, Prof.Dr.         
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Jan Siewe, Dr. University Hospital of Cologne
  More Information

Additional Information:
No publications provided

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
Study First Received: May 8, 2013
Last Updated: April 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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

ClinicalTrials.gov processed this record on July 24, 2014