Clinical trial NCT01461005: A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
Official title: A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spondylolisthesis
Neurologic Deficits
Kyphosis
Pseudarthrosis
Keywords: Spondylolisthesis
Neurologic impairment
Kyphosis
Pseudarthrosis
Lead sponsor: Paradigm Spine
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2011-10-27
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.
timeFrame: 6 months
Secondary outcomes:
measure: Measurement of Lower Back Pain as Assessed by Visual Analog Scale
timeFrame: 6 months
measure: Measurement of Right Leg Pain as Assessed by Visual Analog Scale
timeFrame: 6 months
measure: Measurement of Left Leg Pain as Assessed by Visual Analog Scale
timeFrame: 6 months
measure: Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline.
timeFrame: Pre-Op, 6 weeks, 6 months, 12 months, and 24 months
measure: Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).
timeFrame: 6 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
Study officials:
affiliation: Paradigm Spine LLC
name: Gitela Gandelman
role: STUDY_DIRECTOR
References: