Clinical trial NCT01847898: Study on the Treatment of Osteoporotic Vertebral Fractures Using Vertebral Body Stenting
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vertebral Body Fractures
Keywords: Osteoporosis
Vertebral Body
Compression Fracture
Kyphoplasty
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
First posted: 2013-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 50
2. 1 to 3 contiguous target vertebral compression fractures (VCF) meeting the following criteria:
3. Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis (Patients with AO type A1.x fractures and A3.1 fractures may be included in the study).
4. All target VCFs are between Th5 and L5

   * All target VCFs to be treated show either:

     * Height change: An acute (\< 6 month) change in VB height (\>15% height loss) with height loss at the anterior, middle or posterior portion of the VB consistent with a worsening of 1 or more grades by the Genant criteria, OR
     * Positive MRI or bone scan: VB shows hyperintense signal on MRI-T2 or STIR sequence or target VB is positive on radionuclide bone scan
   * Back pain correlating with the location of at least one VCF
5. Treatment of all target VCFs is technically feasible by and clinically appropriate for BOTH vertebroplasty and balloon kyphoplasty
6. No major surgery to the spine planned for at least 1 month following enrollment
7. Pre-treatment back pain by numerical rating scale (NRS) score \>= 4 (0-10 scale)
8. Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
9. Psychosocially, mentally and physically able to fully comply with the protocol requirements for the duration of the study including adhering to scheduled visits, treatment plan, completing forms and other study procedures

Exclusion Criteria:

1. VB morphology or configuration is such that either balloon kyphoplasty OR vertebroplasty is not technically feasible for the targeted VCFs
2. Fracture due to high-energy trauma
3. Suspected OR proven cancer inside index vertebral body.
4. Disabling back pain due to causes other than acute fracture (e.g., sacroiliac fracture, symptomatic degenerative disc disease, lumbar spinal stenosis)
5. Any painful VCF with fracture age \> 6 months
6. Patients with primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma at site of the index VCF. Patients with these tumors in anatomic sites other than the index VCF are eligible.
7. Any objective evidence of neurologic compromise at baseline
8. Previous balloon kyphoplasty or vertebroplasty for any VCF
9. Spine stabilization beyond balloon kyphoplasty or vertebroplasty required for targeted VCFs
10. Significant clinical comorbidity that may potentially interfere with long-term data collection or follow-up (e.g., dementia, severe comorbid illness)
11. Patients requiring the use of high-dose steroid (\>= 100mg prednisone or 20 mg dexamethasone per day), IV pain medication, or nerve block to control chronic back pain unrelated to index VCF(s). Patients who receive high-dose steroids for treatment of their cancer (for at least 30 days) are eligible.
12. Patients who may require allogeneic bone marrow transplantation during the course of the study
13. Spinal cord compression or canal compromise requiring decompression
14. Patients with osteoblastic tumors at the site of index VCF. Patients with osteoblastic tumors of vertebral levels not intended for kyphoplasty may be enrolled.
15. MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implanted biostimulators, cochlear implants, penile prosthesis)
16. Spinal instability as indicated by neurologic deficit, kyphosis \>30°, compression \>50%, translation \> 4 mm, interspinous-process widening.
17. Pre-existing conditions contrary to either balloon kyphoplasty or vertebroplasty, such as:

    * Irreversible coagulopathy or bleeding disorder. Note regarding reversible coagulopathies: Subjects on coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants.
    * Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty or vertebroplasty. Note that in subjects with allergy to iodine-based contrast, other non-iodine contrast solutions may be used.
    * Any evidence of VB or systemic infection
18. Pregnant or child-bearing potential

Primary outcomes:
measure: Increase and maintenance of the vertebral body height
timeFrame: 12 months
measure: Visual analog scale (VAS) for back pain
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Radiographic evaluations
timeFrame: 2 years
measure: Global assessment by the patient using the VAS
timeFrame: 2 years
measure: VAS leg pain
timeFrame: 2 years
measure: Analgesic usage
timeFrame: 2 years
measure: Neurological assessment of root tension signs, muscle strength, sensory deficit and reflexes
timeFrame: 2 years
measure: Symptoms associated with position/direction of cement extrusion
timeFrame: 2 years
measure: Disability using the Oswestry Disability Index (ODI)
timeFrame: 2 years
measure: Quality of Life Evaluation using the EuroQol, general quality of life questionnaire (EQ-5D)
timeFrame: 2 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinik für Unfallchirurgie
city: Wien
country: Austria
facility: AKH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Münster
country: Germany
facility: Universitätsklinikum
city: Rostock
country: Germany
facility: Universitätsklinik und Poliklinik für Chirurgie
Study officials:
affiliation: Klinik Sonnenhof, Bern, Switzerland
name: Paul F. Heini, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: