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

Interventional Spine

Status

Withdrawn

Conditions

Lumbar Facet Disease

Treatments

Device: PERPOS™ PLS

Study type

Interventional

Funder types

Industry

Identifiers

NCT00887835

PLS-007-FUS

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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