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

NCT00887835 | Withdrawn

• 1 other identifier: PLS-007-FUS
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Lumbar Facet Disease

Keywords

PERPOS fusion

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index and Visual Analogue Scale

  1 year

Study Arms (1)

PERPOS™ PLS

EXPERIMENTAL

Minimally invasive transfacet fixation with PERPOS™ PLS as an aid to fusion

Device: PERPOS™ PLS

Interventions

PERPOS™ PLS DEVICE

To stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints.

PERPOS™ PLS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and males between 18 and 85
• Must have lumbar facet disease confirmed by:
• Documented pain relief with controlled lumbar facet block using local anesthetic or steroid administration; AND
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Interventional Spine, Inc.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2010
• Last Updated: April 27, 2012

Record last verified: 2009-04