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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016954
Enrollment
68
Registered
2019-04-29
Start date
2019-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M81

Interventions

Group 1: Patients receiving a dorsal stabilization of the lumbar spine. All patients receive preoperative measdurements of bone quality using TBS, aBMD and BMSi. Additionally, intraoperative vertebral

Sponsors

Charité Campus Charité Mitte
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
in vivo measurements of bone quality after 12 and 36 months, laboratory parameters of bone metabolism, clinical parameters like vertebral fractures or standardized scores

Countries

Germany

Contacts

Public ContactYannick Palmowski

Charité Campus Charité Mitte

yannick.palmowski@charite.de450622234

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026