A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Interventional Spine, Inc.
ClinicalTrials.gov Identifier:
NCT00887835
First received: April 23, 2009
Last updated: April 25, 2012
Last verified: April 2009
  Purpose

The purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine fixation to evaluate its effect on patients' level of pain, procedural complications and functional status.


Condition Intervention
Lumbar Facet Disease
Device: PERPOS™ PLS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System

Further study details as provided by Interventional Spine, Inc.:

Primary Outcome Measures:
  • Change in Oswestry Disability Index and Visual Analogue Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: April 2009
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PERPOS™ PLS
Minimally invasive transfacet fixation with PERPOS™ PLS as an aid to fusion
Device: PERPOS™ PLS
To stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints.

Detailed Description:

The PERPOS™ PLS System involves a minimally invasive, percutaneous implant procedure via a small incision.

The PERPOS™ PLS is intended for lumbar bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Females and males between 18 and 85
  • Must have lumbar facet disease confirmed by:

    1. Documented pain relief with controlled lumbar facet block using local anesthetic or steroid administration; AND
    2. MRI or CT scan, with or without bone scan, obtained within 3 months of enrollment, confirming arthritic facet joints OR, must have lumbar facet disease (as confirmed above) and are contra-indicated for steroid injections, or non-compliant with conservative pain management treatments, or wish to avoid the side-effects of steroids or prescriptive pain medication treatment
  • Must score at least 4 on a 10-point Visual Analog Scale (VAS) for back pain
  • Must score at least 40% on the Oswestry Disability Index.
  • Must have less than 50% disc height loss
  • Must have no greater than Grade I spondylolisthesis demonstrated on flexion and extension lumbar radiographs taken within 2 months of enrollment
  • Willing and able to comply with the requirements of the protocol including follow-up requirements
  • Willing and able to sign a study specific informed consent.

Exclusion Criteria:

  • Are within the first two PERPOS PLS System utilization experience of the investigator
  • Have severe facet degeneration, radiographic findings of severe facet joint disease, degeneration of misshapen facet(s) or structural anomalies at the target fusion level that would preclude proper placement of the BONE-LOK Implant.
  • Have evidenced malingering behavior related to workman's compensation claims
  • Have had any significant prior intervention (greater than an injection) in the facet joint to be treated, or within two (2) levels above or two (2) levels below the facet joint to be treated
  • Have had prior instrumentation of involved vertebrae at any time
  • Have osteoporotic bone at the lumbar spine level to be treated based on the SCORE (Simple Calculated Osteoporosis Risk Estimation) screening questionnaire, (or a DEXA bone density measured T score <-1.0.).
  • Have scoliosis with lateral angulation >20 degrees
  • Have an active malignancy: A subject with a history of any invasive malignancy (except non-melanoma skin cancer), unless s/he has been treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years.
  • Have a cyst in the canal associated with the facet
  • Have neurologic deficit bowel or bladder dysfunction
  • Have spinal canal or neural foramen compromise
  • Have an infection (local or systemic)
  • Have myelopathy
  • Have abnormal coagulation time
  • Have been or will be on anticoagulation therapy within 10 days of the study procedure
  • Have radiculopathy
  • Have cord compression or canal compromise requiring surgery for decompression
  • Have disabling back pain secondary to another cause
  • Have COPD that poses anesthesia risk
  • Have severe cardiopulmonary deficiencies
  • Have narcotic dependence or >90 days of narcotic pain medications
  • Are morbidly obese (BMI >40)
  • Have uncontrolled diabetes
  • Have known allergies to implant materials, e.g., titanium.
  • Are currently pregnant or lactating or considering becoming pregnant during the follow-up period
  • Have been involved in an investigational drug or device study within the previous 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Interventional Spine, Inc.
ClinicalTrials.gov Identifier: NCT00887835     History of Changes
Other Study ID Numbers: PLS-007-FUS
Study First Received: April 23, 2009
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Interventional Spine, Inc.:
PERPOS fusion

ClinicalTrials.gov processed this record on October 19, 2014