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Completed

NCT Number: NCT04156867

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

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

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Key information

Conditions

Orthopedic Disorder of Spine

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

was Single-segmental LDH with low back pain and radicular pain.

Exclusion criteria

Exclusion criteria

s 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.

Treatment and study plan

Dynesys

Device

discectomy with Dynesys

Primary outcomes

  1. visual analog scale

    Time frame: 2 year

    visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.

  2. Oswestry Disability Index

    Time frame: 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%.

  3. Intervertebral height

    Time frame: 2 year

    Intervertebral height in X-ray is for recontruction of the intervertebral space.

  4. Range of motion(ROM)

    Time frame: 2 year

    ROM was measured by the flexion-extension radiographs of both endplates of the treated segment.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Nov 8, 2019
Registry last updated
Nov 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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