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A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)

A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)

NCT01461005•Paradigm Spine

View on ClinicalTrials.gov

Summary

The purpose of the Post-Market Surveillance study is to evaluate safety.

Detailed Description

Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.

Eligibility

Age

21 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is skeletally mature (21-85 years old).
•Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level.
•Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations.
•Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study.

Exclusion Criteria

•The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications.
•Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general.
•Acute or chronic systemic, spinal or localized infections.
•Active, severe systemic and metabolic diseases.
•Obesity defined as Body Mass Index \> 35.
•Subject is pregnant or interested in becoming pregnant in the next 36 months.
•Dependency on pharmaceutical drugs, drug abuse, or alcoholism.
•Lack of patient cooperation.
•Foreign body sensitivity to the implant material.
•Degenerative scoliosis greater than 25 degrees.
+12 more criteria

Locations (1)

University of California, Davis Medical Center

Sacramento, California, United States

Key Dates

Start Date

September 1, 2011

Primary Completion Date

September 1, 2016

Completion Date

September 1, 2016

Last Updated

February 19, 2020

Enrollment

ACTUAL participants

Conditions

SpondylolisthesisNeurologic DeficitsKyphosisPseudarthrosis

Interventions

Dynamic Stabilization System (DSS)

DEVICE

Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery

NCT04885244

Adult Spinal DeformityScoliosis+2 more

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RECRUITINGPHASE4

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

NCT05029726

Lumbar Spinal StenosisLumbar Disc Herniation+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery

Regional Anesthesia in Minimally Invasive Lumbar Spine Surgery

Effect of Adult Spinal Deformity Surgery on Functional Reach

NeuroVision vs Standard Neuromonitoring

Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)

PREventing Pain After Surgery