Status:
TERMINATED
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
Lead Sponsor:
Paradigm Spine
Collaborating Sponsors:
MCRA
Conditions:
Spondylolisthesis
Neurologic Deficits
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01461005
Start Date
September 1 2011
End Date
September 1 2016
Last Update
February 19 2020
Active Locations (1)
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1
University of California, Davis Medical Center
Sacramento, California, United States, 95816