Evaluation of the TEKTONA® system designed to restore vertebral height in the treatment of vertebral fractures by compressio
Phase 4
Completed
- Conditions
- Vertebral compression fracture, stable type, without neurological deficitMusculoskeletal Diseases
- Registration Number
- ISRCTN10328801
- Lead Sponsor
- Spineart (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
1. Aged 18 years or older
2. Presenting one or more three stable vertebral fractures at non-adjacent levels, fractures type A1.1, A1.2, A1.3, A2 (gap between fragments less than 2 mm) and A3.1, A3.2, A3.3 according to Magerl classification
3. Presenting vertebral traumatic fracture(s), due to high-energy trauma, or osteoporotic fall of one's own height
4. Able to understand the investigation protocol, agree with the investigation plan, and complete the necessary documents
5. Who voluntarily signed the informed consent form
Exclusion Criteria
1. Anterior treatment with cyphoplasty at the fractured level
2. Unstable fractures of type B or C according to Magerl
3. Size of the pedicules incompatible with safe access to the instrument
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Risks are measured by the incidence of perioperative complications and safety reporting and post-operative risks (adverse events reporting, radiological assessments at 6, 12 and 24 months) <br>2. Restoration of vertebral height (mm) and reduction of kyphosis (Cobb Angle) at the level operated is measured by comparing radiological images pre-surgery, perioperative, immediate post-surgery, at 6-, 12- and 24-months post-surgery
- Secondary Outcome Measures
Name Time Method 1. Volume of cement injected and cement distribution (vertebral and horizontal) is measured (in ml) at surgery<br>2. Effectiveness of the system is measured by the duration of post-operative hospitalization<br>3. Pain is evaluated by changes in the use of pain medication and the visual analogue score (VAS) score pre-surgery, immediate post-surgery, at 6-, 12- and 24-months post-surgery<br>4. Quality of life is measured using the SF-12 questionnaire preoperatively, immediate postoperatively and at 6, 12 and 24 months and time between intervention and back to work<br>5. Functional evaluation using Oswestry Disability Index (ODI) score preoperatively, immediate postoperatively and at 6, 12 and 24 months