Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial
NCT ID: NCT03404232
Last Updated: 2018-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2012-01-01
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.).
Dynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.
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.).
Dynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.
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.).
Dynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.
Interventions
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Dynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Aachen
OTHER
Responsible Party
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Christian Herren
Principal Investigator
Locations
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University Hospital Cologne
Cologne, , Germany
Countries
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References
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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.
Other Identifiers
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UKKuUKA001
Identifier Type: -
Identifier Source: org_study_id
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