NL-OMON33026
Recruiting
Not Applicable
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
Alysis Zorggroep0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Alysis Zorggroep
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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)
Outcomes
Primary Outcomes
Not specified
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