prospective follow-up of focal Bone Mineral Density changes in the inter-transverse fusion mass after instrumented single-level posterolateral lumbar spine fusion

prospective follow-up of focal Bone Mineral Density changes in the inter-transverse fusion mass after instrumented single-level posterolateral lumbar spine fusion - Focal BMD- changes after instrumented single level lumbar spine fusion

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33026

Enrollment

Registered

2009-12-24

Start date

2010-01-08

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

single-level posterolateral lumbar spine fusion

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. age 18-80 years 2. low back pain and radicular symptoms caused by lumbar instability 3. leg and/or backpain with one of more of the following phenomena:radiculopathy, sensory deficit, motor weakness, reflex pathology, neurogenic claudication 4. patient has been non-responsive to at least 6 months of non-operative treatment prior to study enrollment 5. fusion of only one lumbar level in the L-3 to S-1 region is indicated

Exclusion criteria

Exclusion criteria: 1. indication for multiple levels fusion based on gross instability 2. severe osteoporotic/osteopenic 3. active spinal and/or systemic infection 4. systemic disease or condition, which would affect ability to participate in the study requirements (i.e. active malignancy)

Design outcomes

Primary

Measure	Time frame
Mean changes in BMD in specific ROI will be evaluated and subsequently be correlated to one year CT-scan data on bony fusion.	—

Secondary

Measure	Time frame
Mean changes in clinical scores (ODI, SF-36, VAS back and leg pain) radiographic evaluation (X-ray and CT-scan)	—

Countries

Netherlands

Outcome results