Prospective crossectional and longitudinal study comparing new in vivo methods for the evaluation of bone quality with intraoperative biopsies in patients with degenerative spine diseases
- Conditions
- M81Osteoporosis without pathological fracture
- Registration Number
- DRKS00016954
- Lead Sponsor
- Charité Campus Charité Mitte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 68
Inclusion Criteria
patients with degenerative diseases of the spine and the indication for a dorsal stabilization of the lumbar spine using pedicle screws
- patients with the indication for osteoporosis diagnostics
- consent to participate
- capacity for consent
Exclusion Criteria
- known tumors
- previous surgery including L1-4
- recent or older changes of the vertebrae L1-4 (e.g. fractures)
- BMI >35
- Patients with serious damages of the central or peripheral nervous system
- Incompliance
- alcohol, drug or medicine-dependency
- serious psychiatric diseases limiting the understanding of the project plan and the study protocol
- pregnant and breast feeding patients
- patients not able to give consent for any reasons
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method crosssectional: parameters of bone quality (µCT and histomorphometry of vertebral biopsies as well as in vivo DXA, TBS and BMSi preoperatively) longitudinally: material faillure after 12 and 36 months
- Secondary Outcome Measures
Name Time Method in vivo measurements of bone quality after 12 and 36 months, laboratory parameters of bone metabolism, clinical parameters like vertebral fractures or standardized scores