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

N

Nanjing Medical University

Status

Completed

Conditions

Orthopedic Disorder of Spine

Treatments

Device: Dynesys

Study type

Interventional

Funder types

Other

Identifiers

NCT04156867
KY201410933-56

Details and patient eligibility

About

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

Full 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.

Enrollment

128 patients

Sex

All

Ages

35 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

128 participants in 1 patient group

simple discectomy
Experimental group
Description:
traditional simple discectomy
Treatment:
Device: Dynesys

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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