Spine Surgery
Conditions
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.
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.
Interventions
DEVICEDynesys DTO device (Zimmer Spine, Inc.)
All patients receive posterior hybrid instrumentation.
Sponsors
University Hospital, Aachen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the health-related outcome measurement instruments (ODI) | 24-48 months | — |
| Changes in the health-related outcome measurement instruments (COMI) | 24-48 months | — |
| Changes in the health-related outcome measurement instruments (SF-36) | 24-48 months | — |
| Radiological outcomes | 24-48 months | Radiological changes within the adjacent segment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device complication (breakage, loosening, etc.) | 24 - 48 months | Complication regarding the device |
| Patient-related complication | 24- 48 months | general and surgical complication |
Countries
Germany
Outcome results
None listed