Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation

Study Overview
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Brief Summary
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To explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy.

Detailed Description
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The study was to explore the clinical outcomes of discectomy with dynamic neutralization system(Dynesys) on treatment of single-segmental lumbar disc herniation(LDH) versus simple discectomy. 128 patients with single-segmental LDH were randomly divided into discectomy with Dynesys group(group A) and simple discectomy group(group B). Both groups were evaluated by Visual Analogue Score(VAS), Oswestry Disability Index(ODI), radiological evidence of intervertebral height and range of motion(ROM) of the treated segment at pre- and post-operation. Operation duration and blood loss was recorded. The clinical outcomes and complications were evaluated afterwards. All patients received a 2-year follow-up.

Official Title
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Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation: a Prospective Study

Conditions
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Orthopedic Disorder of Spine

Intervention / Treatment
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* Device: Dynesys


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria was Single-segmental LDH with low back pain and radicular pain. Exclusion Criteria: Exclusion criterias were lumbar stenosis(LSS), lumbar spondylolysis and degenerative spondylolisthesis, spinal deformity, lumbar surgery history, obviously osteoporosis, vertebral fracture, cauda equina syndrome, ankylosing spondylitis, tuberculosis, infection, tumor, obesity.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 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: simple discectomy<br>traditional simple discectomy | Device: Dynesys<br>* discectomy with Dynesys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain. | 2 year | 
| Oswestry Disability Index | Oswestry Disability Index is for movement function, Questionnaire examines perceived level of disability in everyday activities of daily living. The ODI score (index) is calculated as: For example: If all 10 sections are completed, the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%; If one section is missed (or not applicable), the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%. | 2 year | 
| Intervertebral height | Intervertebral height in X-ray is for recontruction of the intervertebral space. | 2 year | 
| Range of motion(ROM) | ROM was measured by the flexion-extension radiographs of both endplates of the treated segment. | 2 year |