Radiological and Clinical Efficacy of a Hybrid Spinal Implant ("Topping Off"): a Mono-center, Prospective Clinical Trial
Not Applicable
Completed
- Conditions
- Spine Surgery
- Interventions
- Device: Dynesys DTO device (Zimmer Spine, Inc.)
- Registration Number
- NCT03404232
- Lead Sponsor
- University Hospital, Aachen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Dynesys DTO device (Zimmer Spine, Inc.) patients with a previous surgical decompression but non-fusion procedure after lumbar spinal stenosis surgery receive the Dynesys DTO device (Zimmer Spine, Inc.). Group 1 Dynesys DTO device (Zimmer Spine, Inc.) patients with their first surgical intervention at the lumbar spine receive the Dynesys DTO device (Zimmer Spine, Inc.). Group 3 Dynesys DTO device (Zimmer Spine, Inc.) 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.).
- Primary Outcome Measures
Name Time Method Changes in the health-related outcome measurement instruments (SF-36) 24-48 months Changes in the health-related outcome measurement instruments (COMI) 24-48 months Changes in the health-related outcome measurement instruments (ODI) 24-48 months Radiological outcomes 24-48 months Radiological changes within the adjacent segment
- Secondary Outcome Measures
Name Time Method Patient-related complication 24- 48 months general and surgical complication
Device complication (breakage, loosening, etc.) 24 - 48 months Complication regarding the device
Trial Locations
- Locations (1)
University Hospital Cologne
🇩🇪Cologne, Germany