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

Not Applicable

Completed

• Conditions: Orthopedic Disorder of Spine
• Interventions: Device: Dynesys

• Registration Number: NCT04156867
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2017-12-31
• Study Completion: 2018-03-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Study First Posted: 2019-11-08
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
simple discectomy	Dynesys	traditional simple discectomy

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	2 year	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%.
Range of motion(ROM)	2 year	ROM was measured by the flexion-extension radiographs of both endplates of the treated segment.
visual analog scale	2 year	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Intervertebral height	2 year	Intervertebral height in X-ray is for recontruction of the intervertebral space.