Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting
This is a randomized, controlled study to document and evaluate the clinical performance of the Vertebral Body Stenting (VBS) System in osteoporotic fractures of the thoracic and lumbar spine.
The randomized, controlled trial (RCT) will compare patients with VBS and Balloon Kyphoplasty.
|Vertebral Body Fractures||Procedure: Vertebral Body Stenting (VBS) Procedure: Balloon Kyphoplasty||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Study to Evaluate the Clinical Performance of the VBS System for the Treatment of Osteoporotic Vertebral Fractures in a Multicenter, Randomized, Controlled Setting|
- Increase and maintenance of the vertebral body height [ Time Frame: 12 months ]The anterior edge, mid height and posterior edge of the index vertebral body are measured pre-operatively standing, after prone intraoperative positioning on the table (dynamic fracture mobility), intra-operatively following balloon dilation (height restoration), after balloon deflation and removal, after cement deposition, and finally postoperative standing. Anterior, middle and posterior height measurements will be made at each time-point during the study to measure maintenance of vertebral body height over time. The ratio between anterior and mid or posterior edge height (Beck-index) is calculated to avoid the problem of image calibration. In addition, the relative height fractions in comparison to the nearest healthy vertebral body (referent level) are calculated. Finally, local and regional sagittal angles and overall lumbar lordosis or thoracic kyphosis, respectively, are assessed for measurement of improvement of alignment.
- Visual analog scale (VAS) for back pain [ Time Frame: 12 months ]Pain assessment by the patients using the VAS back pain from 0 to 10. In this scale 0 means "no pain" and 10 is the "worst pain imaginable". A pre- to postoperative difference of at least 2 observed during the course of the therapy is regarded as clinically relevant.
- Adverse events [ Time Frame: 12 months ]
- Any re-operations, revisions, and removals or supplemental fixation at the index level(s) is considered a study failure.
- Any intra-operative system malfunction, misplacement of the balloon or stent, balloon or stent fracture, or failure of the balloon or stent to fully deploy is considered a study failure.
- Radiographic evaluations [ Time Frame: 2 years ]Evaluation of osteolysis surrounding the VBS System and/or cement; Evaluation of adjacent level arthritis; Evaluation of bridging trabecular bone at intradiscal spaces adjacent to the treated level(s); Assessment of segmental kyphosis/lordosis at the treated and adjacent level(s) Evaluation of all vertebral body fractures directly above and below the treated level(s
- Global assessment by the patient using the VAS [ Time Frame: 2 years ]Patients globally assess their overall satisfaction with the treatment using the VAS, where 0 = totally dissatisfied and 10 = totally satisfied. A six-level question comparing the current situation to the preoperative state of health is also used.
- VAS leg pain [ Time Frame: 2 years ]VAS leg pain from 0 to 10. In this scale 0 means "no pain" and 10 is the "worst pain imaginable".
- Analgesic usage [ Time Frame: 2 years ]Analgesic consumption is documented in the categories - none, Paracetamol (Acetaminophen), Nonsteroidal anti-inflammatory drugs (NSAID), Metamizole, mild opiates and strong opiates at baseline and each follow-up office visit. This information is obtained with the help of medical staff or the patient's family and relatives.
- Neurological assessment of root tension signs, muscle strength, sensory deficit and reflexes [ Time Frame: 2 years ]Assessment of root tension signs (yes/no), muscle strength (normal/decreased), sensory deficit (yes/no) and reflexes (normal/decreased/increased) will be conducted at baseline and each follow-up visit
- Symptoms associated with position/direction of cement extrusion [ Time Frame: 2 years ]Symptoms associated with position/direction of cement extrusion: epidural, pulmonary, intradiscal, large vessels, foraminal, paraspinal soft tissue, paravertebral vessels, other.
- Disability using the Oswestry Disability Index (ODI) [ Time Frame: 2 years ]Oswestry Disability Index (ODI), version 2.1 will be used.
- Quality of Life Evaluation using the EuroQol, general quality of life questionnaire (EQ-5D) [ Time Frame: 2 years ]The EQ-5D (EuroQol, general quality of life questionnaire) will be used.
|Actual Study Start Date:||September 1, 2009|
|Study Completion Date:||December 31, 2015|
|Primary Completion Date:||December 31, 2015 (Final data collection date for primary outcome measure)|
|Experimental: Vertebral Body Stenting (VBS)||
Procedure: Vertebral Body Stenting (VBS)
Vertebral Augmentation with a Stent
|Experimental: Balloon Kyphoplasty||
Procedure: Balloon Kyphoplasty
Vertebral Augmentation with a Balloon (device not specified)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01847898
|Universitätsklinik für Unfallchirurgie|
|Universitätsklinik und Poliklinik für Chirurgie|
|Principal Investigator:||Paul F. Heini, Prof. Dr. med.||Klinik Sonnenhof, Bern, Switzerland|