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

Orthopedic Disorder of Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156867
• Other study ID #: KY201410933-56
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: March 1, 2018

Study information

• Verified date: November 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 1, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder of Spine
• Spinal Diseases

Intervention

Device:
• Dynesys
discectomy with Dynesys

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale	visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.	2 year
Primary	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
Primary	Intervertebral height	Intervertebral height in X-ray is for recontruction of the intervertebral space.	2 year
Primary	Range of motion(ROM)	ROM was measured by the flexion-extension radiographs of both endplates of the treated segment.	2 year