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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-09-30

Brief Summary

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

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Detailed Description

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

Conditions

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Spondylolisthesis Neurologic Deficits Kyphosis Pseudarthrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dynamic Stabilization System

Dynamic Stabilization System (DSS) System

Group Type EXPERIMENTAL

Dynamic Stabilization System (DSS)

Intervention Type DEVICE

Dynamic Stabilization System

Interventions

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Dynamic Stabilization System (DSS)

Dynamic Stabilization System

Intervention Type DEVICE

Eligibility Criteria

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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.
* Grade 4 degenerative spondylolisthesis (\>75% slip).
* Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required\*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia).
* Soft tissue deficit not allowing wound closure.
* Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device.
* Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae.
* Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication.
* Pars defect.
* Clinically compromised vertebral bodies at affected level due to current or past trauma.
* Prisoner or ward of the state.
* Currently in litigation regarding a spinal condition.
* Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents.
* Is currently involved in a study of another investigational product for similar purpose.

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No