Demineralized bone matrix (DBM putty) versus iliac crest bone graft for anterior single-level interbody fusion in thoracolumbar fractures. A prospective randomized controlled pilot trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021632

Enrollment

Registered

2020-05-05

Start date

2008-06-09

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

S22.0 S32.0

Interventions

Group 1: anterior intervertebral fusion using a titanium cage with demineralized bone matrix (5 cc) placed left lateral to the cage plus anterior single-level locking-plate fixation via anterior spina

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: age 18-65 years, unstable fractures of the thoracic and lumbar spine

Exclusion criteria

Exclusion criteria: - age 65 years - osteoporotic vertebral fracture - condition of pre-diagnosed osteoporosis - condition of pre-diagnosed spinal tumors - condition of pre-diagnosed osseous disease (e.g. Osteogenesis imperfecta) - condition of pre-diagnosed Parkinson's disease

Design outcomes

Primary

Measure	Time frame
WHAT: Assessment of biological intervertebral fusion, i.e. a contiguous bony bridging of the surgically treated intervertebral space WHEN: postoperatively after 9 months HOW: Evaluation of successful intervertebral fusion by comparing two computed tomography (CT) scans per patient (1st CT: performed few days postoperatively; 2nd CT: performed after 9 months postoperatively). In the DBM-group, densitometry is carried out based on correlating CT data sets (a density increase in the assessment filter of >100 Hounsfield Units (suitable for examining cancellous bone formation) and in the assessment filter of >500 Hounsfield Units (suitable for examining cortical bone formation)). In the control group (iliac crest bone grafting), CT scans after nine months postoperatively are evaluated for visible contiguous bony bridging of surgically treated intervertebral spaces in at least two consecutive coronal and sagittal image slices. The need to use different evaluation methods in study groups is extensively discussed in the article.	—

Measure

Time frame

WHAT: Assessment of biological intervertebral fusion, i.e. a contiguous bony bridging of the surgically treated intervertebral space WHEN: postoperatively after 9 months HOW: Evaluation of successful intervertebral fusion by comparing two computed tomography (CT) scans per patient (1st CT: performed few days postoperatively; 2nd CT: performed after 9 months postoperatively). In the DBM-group, densitometry is carried out based on correlating CT data sets (a density increase in the assessment filter of >100 Hounsfield Units (suitable for examining cancellous bone formation) and in the assessment filter of >500 Hounsfield Units (suitable for examining cortical bone formation)). In the control group (iliac crest bone grafting), CT scans after nine months postoperatively are evaluated for visible contiguous bony bridging of surgically treated intervertebral spaces in at least two consecutive coronal and sagittal image slices. The need to use different evaluation methods in study groups is extensively discussed in the article.

—

Secondary

Measure	Time frame
- recovery of pre-traumatic activity levels after nine months (evaluated by VAS Spine Score) [according to Knop C, Oeser M, Bastian L, Lange U, Zdichavsky M, Blauth M (2001) Entwicklung und Validierung des VAS-Wirbelsäulenscores [Development and validation of the Visual Analogue Scale (VAS) Spine Score]. Unfallchirurg 104(6):488–497. doi:10.1007/s001130170111] - loss of reduction after nine months evaluated on lateral X-rays in standing position - procedure-specific complication rate	—

Measure

Time frame

- recovery of pre-traumatic activity levels after nine months (evaluated by VAS Spine Score) [according to Knop C, Oeser M, Bastian L, Lange U, Zdichavsky M, Blauth M (2001) Entwicklung und Validierung des VAS-Wirbelsäulenscores [Development and validation of the Visual Analogue Scale (VAS) Spine Score]. Unfallchirurg 104(6):488–497. doi:10.1007/s001130170111] - loss of reduction after nine months evaluated on lateral X-rays in standing position - procedure-specific complication rate

—

Countries

Germany

Contacts

Public ContactHorst Balling

Neckar-Odenwald-Kliniken gGmbH

horst.balling@neckar-odenwald-kliniken.de06281 29 5163

Outcome results

None listed

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