Dynesys Spinal System Post Market 522 Study

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.

Detailed Description
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Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.

Official Title
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Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.

Conditions
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Degenerative Spondylolisthesis, Pseudoarthrosis

Intervention / Treatment
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* Device: Dynesys Spinal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature between the ages of 20-80 Candidate for posterior lateral fusion between T1-S1 with autograft Degenerative spondylolisthesis with evidence of neurologic impairment or failed previous fusion (pseudoarthrosis) Symptoms of leg and/or back pain Non-responsive to conservative/non-surgical treatment for at least three (3) months Must be willing and able to comply with study requirements; including complete necessary study paperwork and return for required follow-up visits Exclusion Criteria: Active systemic or local infection Obesity Use of interbody device Pregnancy Mental illness Incarceration Alcohol or drug abuse Severe osteoporosis or osteopenia Use in the cervical spine Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate Soft tissue deficit not allowing sound closure Any medical or physical condition that would preclude the potential benefit of spinal implant surgery Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device Active malignancy or other significant medical comorbidities Any medical or mental condition which would put the patient at high risk due to the severity of surgery Inadequate pedicles of the thoracic, lumbar and sacral vertebrae Patient unwilling or unable to follow postoperative instructions

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynesys System<br>All patients will receive the Dynesys System and all patients will be compared to historical literature control. Dynesys Spinal System will be used for all subjects. | Device: Dynesys Spinal System<br>* Dynesys Spinal System will be used for all subjects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Rates | Fusion was defined by meeting three criteria: rotation < 5° between motion segments on flexion-extension radiographs translation < 3 mm between motion segments on flexion-extension radiographs presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control. | 24 months post surgery date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dynesys Dynamic Stabilization System, Spondylolithesis, pseudoarthrosis, neurologic impairment, failed fusion