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Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial

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ClinicalTrials.gov Identifier: NCT03404232
Recruitment Status : Completed
First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Christian Herren, University Hospital, Aachen

Study Description
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Brief Summary:
The study aim is to show the effectiveness of a hybrid system (DTO) regarding clinical outcome and radiological alteration in a single-center prospective setting.

Condition or disease Intervention/treatment Phase
Spine Surgery Device: Dynesys DTO device (Zimmer Spine, Inc.) Not Applicable

Detailed Description:

Posterior spondylodesis and monosegmental intervertebral cage plus flexible instrumentation of the superiorly adjacent segment (Dynesys DTO).

Planned follow-up visits up to 48 months with documentation of health-related outcome measurement instruments and radiological control of possible segment alteration and device-related complication.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All patients requiring lumbar spinal surgery by the use of a hybrid spinal implant (DTO): (1) patients with their first surgical intervention at the lumbar spine, (2) patients with a previous surgical decompression but non-fusion procedure after LSS and (3) patients with medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of the DTO Hybrid Dynamic Device: a Clinical Outcome- and Radiological-based Prospective Clinical Trial
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.).
 Device: Dynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.
Active Comparator: Group 2
patients with a previous surgical decompression but non-fusion procedure after lumbar spinal stenosis surgery receive the Dynesys DTO device (Zimmer Spine, Inc.).
 Device: Dynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.
Active Comparator: Group 3
patients with the medical history of PLIF-/TLIF-technique and later onset of symptomatic ASD within the superior adjacent segment receive the Dynesys DTO device (Zimmer Spine, Inc.).
 Device: Dynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in the health-related outcome measurement instruments (ODI) [ Time Frame: 24-48 months ]
  2. Changes in the health-related outcome measurement instruments (COMI) [ Time Frame: 24-48 months ]
  3. Changes in the health-related outcome measurement instruments (SF-36) [ Time Frame: 24-48 months ]
  4. Radiological outcomes [ Time Frame: 24-48 months ]
    Radiological changes within the adjacent segment


Secondary Outcome Measures :
  1. Device complication (breakage, loosening, etc.) [ Time Frame: 24 - 48 months ]
    Complication regarding the device

  2. Patient-related complication [ Time Frame: 24- 48 months ]
    general and surgical complication


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Legal capacity
  • Age ≥ 18 years
  • Indication for monosegmental lumbar spine fusion (PLIF or "topping-off ") L2-S1 with osteochondrosis Modic grades I-III or spondylolisthesis Meyerding grades I-III.
  • Radiologic signs of degeneration in the adjacent segment of the intended fusion without signs of instability

Exclusion Criteria:

  • Motor deficit
  • Cauda equina syndrome
  • Previous surgical intervention of the lumbar spine
  • Relevant peripheral neuropathy
  • Acute denervation subsequent to a radiculopathy
  • Scoliosis with Cobb angle greater than 25°
  • Spondylolisthesis > Meyerding grade III
  • Radiologic signs of degeneration in the adjacent segment of the intended fusion with signs of instability (for definition, see inclusion criteria)
  • No radiologic signs of degeneration in the adjacent segment of the intended fusion (for definition, see inclusion criteria)
  • Radiologic signs of degeneration in the adjacent segment of the intended fusion with >Fujiwara grade II or >Pfirrmann grade IV
  • Signs of instability in any lumbar spine segment other than that undergoing fusion
  • General contraindication for elective lumbar spine surgery
  • Pathologic fracture
  • Osteoporosis with pathologic fracture
  • Active systemic infection
  • Rheumatic disease
  • Disease of bone metabolism (e.g. Paget's Disease)
  • Bone metastasis
  • Local infection focus lumbar spine
  • Seizure disorder
  • Chronic ischemia Fontaine classification IIb-IV
  • Severe heart insufficiency (NYHA III-IV)
  • Blood coagulation disorder or blood thinning therapy
  • Cortisone intake more than one month in the last 12 months before randomization
  • Simultaneous participation in another clinical trial in the 30 days before randomization
  • Known allergy or intolerance to the implants
  • Dependency on investigator
  • Lack of familiarity with the German language
  • Placement in an institution by governmental or juridical advice
  • Absent legal capacity
  • Pregnancy
Contacts and Locations
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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): NCT03404232


Locations
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Germany
University Hospital Cologne
Cologne, Germany, 50937
Sponsors and Collaborators
University Hospital, Aachen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christian Herren, Principal Investigator, University Hospital, Aachen
ClinicalTrials.gov Identifier: NCT03404232    
Other Study ID Numbers: UKKuUKA001
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No