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CompletedNCT03404232Updated Jan 19, 2018

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

An interventional study of Dynesys DTO device (Zimmer Spine, Inc.) in Spine Surgery, sponsored by University Hospital, Aachen. Completed at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-01-19.

Sponsored by University Hospital, Aachen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spine Surgery
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • 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.)

  • 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.)

  • 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.)

Interventions

  • DeviceDynesys DTO device (Zimmer Spine, Inc.)

    All patients receive posterior hybrid instrumentation.

05

What researchers measure

Primary outcomes

  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

    Radiological changes within the adjacent segment

    Time frame: 24-48 months

Secondary outcomes

  1. Device complication (breakage, loosening, etc.)

    Complication regarding the device

    Time frame: 24 - 48 months

  2. Patient-related complication

    general and surgical complication

    Time frame: 24- 48 months

06

Study locations

1 site
  • University Hospital Cologne
    Cologne, 50937, Germany
07

References and documents

Publications

  • Herren C, Sobottke R, Pishnamaz M, Scheyerer MJ, Bredow J, Westermann L, Berger EM, Oikonomidis S, Eysel P, Siewe J. The use of the DTO hybrid dynamic device: a clinical outcome- and radiological-based prospective clinical trial. BMC Musculoskelet Disord. 2018 Jun 21;19(1):199. doi: 10.1186/s12891-018-2103-x. PubMed 30016956 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03404232
Lead sponsor
University Hospital, Aachen
Responsible party
Christian Herren (Principal Investigator, University Hospital, Aachen) — Principal investigator
First posted
Jan 19, 2018
Start date
Jan 1, 2012
Primary completion
Dec 31, 2016
Completion
Dec 31, 2017
Last update
Jan 19, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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