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Muscular amyloid deposits as molecular pathomechanism in muscular insufficiency of degenerative spinal diseases

Muscular amyloid deposits as molecular pathomechanism in muscular insufficiency of degenerative spinal diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00013280
Enrollment
50
Registered
2017-11-15
Start date
2017-11-01
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

Clinical relevance of amyloid deposits in the ligamentum flavum and muscle M47

Interventions

Group 1: Patients with several degenerative spinal diseases, who undergo surgery for spondylodesis: immunhistochemical analysis for amyloid-deposits in ligamentum flavum and paravertebrale muscule tis

Sponsors

Universitätsklinikum BG Bergmannsheil GmbH Neurochirurgie und Traumatologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Arm1: Patients, where a dorsal surgery (decompression, spondylodesis) of the thoracolumbar spine is indicated based on a degenerative spine disease For the control-group: Patients that do not suffer from a degenerative spine disease but have to undergo surgery based on a "non degenerative" indikation, like spinal trauma or spinal tumour

Exclusion criteria

Exclusion criteria: - patients that are unable to be informed - pregnancy - patients with a diagnosed autoimmune- or muscle disease - patients with rheuma or a tumour (the control group can be included in cases of a spinal tumour) - patients that are undertaking an oral or intravenal cortisone, cytostatical or immunesuppressive therapy - patients that are unable to give written consent

Design outcomes

Primary

MeasureTime frame
Aim of this study is the clinical significance of amyloid deposits in the ligamentum flavum and muscle (paraspinal musculature) in degenerative changes of the spinal column (e. g. muscle fatigue or hypertrophy of the ligamentum flavum), on the progression of lumbar spinal degeneration before and after lumbar operations of the thoracolumbar vertebral column. In this research project, biopsies of the ligamentum flavum and the paravertebral musculature are collected prospectively during the surgical procedure at the access area. The biopsies taken are to be examined for sarcolematous and interstitial amyloid deposits as well as for histological features indicating muscle degeneration. To this end, hematoxyline-eosin staining and immunohistochemical detection of transthyretin-amyloid will be performed. Transthyretin is also to be measured in the serum of these patients. In addition, the serum level of the inflammation marker IL-1ß is to be determined. The experimental findings will then be correlated with clinical data during the course of the study (sonography - pre-surgical, after 6 weeks, 6 months and 1 year in each case; MRI - pre-surgical and after 6 months - and e. g. VAS - after 6 months and 1 year). The follow-ups extend for 1 year after surgery.

Countries

Germany

Contacts

Public ContactBogdan Pintea (Deputy Prinicipal Investigator)

Universitätsklinikum BG Bergmannsheil GmbH

bogdan.pintea@bergmannsheil.de0234-302-6600

Outcome results

None listed

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