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

Paradigm Spine

Status

Terminated

Conditions

Spondylolisthesis

Pseudarthrosis

Kyphosis

Neurologic Deficits

Treatments

Device: Dynamic Stabilization System (DSS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01461005

Dynamic Stabilization System

Details and patient eligibility

About

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

Full description

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

Enrollment

1 patient

Sex

All

Ages

21 to 85 years old

Volunteers

No 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.
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.