Comparison of Standard Fusion With Topping Off-System in Lumbar Spine

Study Overview
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Brief Summary
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Does a new topping-off device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?

Detailed Description
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Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS). Key secondary endpoint(s): Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 Individual dimensions of the Oswestry Disability Index (ODI) Time until radiological adjacent instability and comparison to the clinical outcome Capacity of work at the time of surgery and after surgery, time until return to work Assessment of safety: Treatment complication in control and intervention groups (SAE-management) A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias

Official Title
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Clinical Trial of the Efficacy of Hybrid Systems(Topping Off)in Comparison to the Conventional Spondylodesis in Fusion-surgery in the Lumbal Spine: a Prospective, Randomised Study

Conditions
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Spondylolisthesis, Erosive Osteochondrosis in L2-S1

Intervention / Treatment
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* Device: Topping off system
* Device: monosegmental PLIF


Participation Criteria
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Eligibility Criteria
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Key inclusion criteria: Male or female >30 years of age Lumbar spine pathology with indication for monosegmental PLIF Radiological signs of a degeneration of the adjacent segment without instability Key exclusion criteria: 1. Radiological signs of existing instability of the adjacent segment 2. Normal endplates and no disc desiccation in MRI in the adjacent seg-ment 3. Previous surgery of the lumbar spine -

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm1: topping off system<br>The intervention group will receive a topping off system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion). | Device: Topping off system<br>* The intervention group will receive a topping off system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).<br>* Other names: Topping off;|
| Other: Arm 2: monosegmental PLIF<br>The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis) | Device: monosegmental PLIF<br>* The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF36 | Primary efficacy endpoint: The baseline and follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline of the SF-36 (Short-Form-36)-Measured Outcome regarding the Physical Component Summary (PCS). | 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36 | 1. Mental Component Summary (MCS) and individual dimensions and subscales of the SF-36 follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline | 6 weeks | 
| Safety | Assessment of safety: Treatment complication in control and intervention groups (SAE-management) A rating committee will provide consistency of the procedure and the assessment of data (e.g. by intraoperative photos, surgery reports, x-rays) to minimize bias | all time | 
| Individual dimensions of the Oswestry Disability Index (ODI) | Individual dimensions of the Oswestry Disability Index (ODI) follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline | 6weeks | 
| Time until radiological adjacent instability and comparison to the clinical outcome | Time until radiological adjacent instability and comparison to the clinical outcome follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline | 6 weeks | 
| Capacity of work at the time of surgery and after surgery, time until return to work | Capacity of work at the time of surgery and after surgery, time until return to work follow-up values after 6 weeks after the operation as well as 6 and 12 months after baseline | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar spine, fusion, adjacent instability, topping-off.