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

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

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

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder of Spine
• Intervention / Treatment: Device: Dynesys

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 Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: simple discectomy; traditional simple discectomy	Device: Dynesys; discectomy with Dynesys

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Bone Diseases; Hernia; Intervertebral Disc Displacement; Musculoskeletal Diseases; Spinal Diseases
• Other Study ID Numbers: KY201410933-56

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No