NCT04156867

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

3.4 years

First QC Date

November 6, 2019

Last Update Submit

November 6, 2019

Conditions

Orthopedic Disorder of Spine

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

simple discectomy

EXPERIMENTAL

traditional simple discectomy

Device: Dynesys

Interventions

DynesysDEVICE

discectomy with Dynesys

simple discectomy

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

August 1, 2014

Primary Completion

December 31, 2017

Study Completion

March 1, 2018

Last Updated

November 8, 2019

Record last verified: 2019-11