Status:
COMPLETED
Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial
Lead Sponsor:
University Hospital, Aachen
Conditions:
Spine Surgery
Eligibility:
All Genders
18-90 years
Phase:
NA
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 documentati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03404232
Start Date
January 1 2012
End Date
December 31 2017
Last Update
January 19 2018
Active Locations (1)
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1
University Hospital Cologne
Cologne, Germany, 50937