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

Recruiting

• Conditions: single-level posterolateral lumbar spine fusion; 10028377; 10005944

• Registration Number: NL-OMON33026
• Lead Sponsor: Alysis Zorggroep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mean changes in BMD in specific ROI will be evaluated and subsequently be<br /><br>correlated to one year CT-scan data on<br /><br>bony fusion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mean changes in clinical scores (ODI, SF-36, VAS back and leg pain)<br /><br>radiographic evaluation (X-ray and CT-scan) </p><br>