Back to resultsEvaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation
Primary Purpose
Orthopedic Disorder of Spine
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynesys
Sponsored by
About this trial
This is an interventional treatment trial for Orthopedic Disorder of Spine
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
simple discectomy
Arm Description
traditional simple discectomy
Outcomes
Primary Outcome Measures
visual analog scale
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
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%.
Intervertebral height
Intervertebral height in X-ray is for recontruction of the intervertebral space.
Range of motion(ROM)
ROM was measured by the flexion-extension radiographs of both endplates of the treated segment.
Secondary Outcome Measures
Full Information
NCT ID
NCT04156867
First Posted
November 6, 2019
Last Updated
November 6, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04156867
Brief Title
Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation
Official Title
Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation: a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder of Spine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
simple discectomy
Arm Type
Experimental
Arm Description
traditional simple discectomy
Intervention Type
Device
Intervention Name(s)
Dynesys
Intervention Description
discectomy with Dynesys
Primary Outcome Measure Information:
Title
visual analog scale
Description
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Time Frame
2 year
Title
Oswestry Disability Index
Description
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%.
Time Frame
2 year
Title
Intervertebral height
Description
Intervertebral height in X-ray is for recontruction of the intervertebral space.
Time Frame
2 year
Title
Range of motion(ROM)
Description
ROM was measured by the flexion-extension radiographs of both endplates of the treated segment.
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Outcomes of Discectomy With Dynesys in Treatment of Lumbar Disc Herniation
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