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

NCT01852526 | Terminated DMC

• 2 other identifiers: Uni-Koeln-1510AAG-I-H-1110
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

degenerative disc disease; spondylolisthesis; Lumbar spine; fusion; adjacent instability

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  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

  6 month

Secondary Outcomes (3)

• SF-36

  6 weeks and 6 ,12,24,36 months

• Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36

  6 weeks,6, 12,24 and 36 months after baseline

• COMI questionnaire (version 2008)-

  6 weeks, 6, 12, 24, 36 month after baseline

Study Arms (2)

hybrid system

EXPERIMENTAL

hybrid system (PLIF + flexible pedicle screw system above the fusion) (Dynamic Rod®: AESCULAP AG, Tuttlingen: Germany

Device: Experimental: hybrid system; Device: Active Comparator: Plif

Plif posterior lumbar intervertebral fusion

ACTIVE COMPARATOR

Conventional monosegmental posterior lumbar intervertebral fusion (PLIF) (Fixateur: S4®: AESCULAP AG, Cage: Wave® Cage, Fa. AMT®)

Device: Experimental: hybrid system; Device: Active Comparator: Plif

Interventions

Experimental: hybrid system DEVICE

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

Also known as: D-Rod

Plif posterior lumbar intervertebral fusion; hybrid system

Active Comparator: Plif DEVICE

monosegmental PLIF

Also known as: S4® AESCULAP AG, Cage: Wave® Cage, Fa. AMT®

Plif posterior lumbar intervertebral fusion; hybrid system

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Radiological signs of existing instability of the adjacent segment
• Normal endplates and no disc desiccation in MRI in the adjacent seg-ment
• Previous surgery of the lumbar spine

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (2)

University hospital, Department of orthopedics & traumasurgery

Cologne, North Rhine-Westphalia, 50924, Germany

Location

University hospital, Department of orthopedics

Halle, Saxony-Anhalt, 06112, Germany

Location

Related Publications (1)

• Siewe J, Bredow J, Oppermann J, Koy T, Delank S, Knoell P, Eysel P, Sobottke R, Zarghooni K, Rollinghoff M. Evaluation of efficacy of a new hybrid fusion device: a randomized, two-centre controlled trial. BMC Musculoskelet Disord. 2014 Sep 5;15:294. doi: 10.1186/1471-2474-15-294.

  PMID: 25189113 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Spondylolisthesis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jan Siewe, Dr.

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.med.

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 13, 2013
• Study Start: March 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

DE (2)