Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain

Sponsor

American British Cowdray Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01918943

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis.

Many techniques evolved since then, from wiring, rods, pedicle screws, and recently inter-spinous fixation devices like the Aspen. Along its evolutionary trail, various methods for achieving circumferential fusion have arisen. Distinct from staged anterior/posterior fusion techniques, two methods of achieving an interbody fusion from a posterior approach have emerged: posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF). Recently, the lateral approach for interbody fusion (XLIF) has became a more common technique, requiring in some cases, complemental posterior fixation with pedicle screws, facet screws or interspinous fixation devices like the Aspen device.

In this study, we address the clinical and radiological outcome of a novel technique using standard PLIF interbody fusion and insertion of the Aspen device via posterior lumbar approach.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Spondylolisthesis Spondylosis Spinal Instability Spinal Stenosis	Device: PLIF and Aspen (spinous process fixation device)

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain in the Presence of Lumbar Instability and Degenerative Disk Disease

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2015

Anticipated Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
PLIF and Aspen device patients All patients will receive PLIF and Aspen device	Device: PLIF and Aspen (spinous process fixation device) Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device

Arm

Intervention/Treatment

PLIF and Aspen device patients

All patients will receive PLIF and Aspen device

Device: PLIF and Aspen (spinous process fixation device)

Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device

Outcome Measures

Primary Outcome Measures

Oswestry Disability Index Score Change [12 months]
Change between Oswestry Disability Index between pre-operative and final 12 months socores

Secondary Outcome Measures

Rolland Morris Score [12 months]
Change in score in the Rolland Morris Score (RMS)
Visual Analogue Scale [12 months]
Change in pain measured by the visual analogue scale
Bone fusion (arthrodesis) [12 months]
Adequate bone fusion measured by computed tomography (CT) scan

Other Outcome Measures

Operative parameters [At surgery]
Surgery time, blood loss

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Oswestry Disability Index score >30%
Diagnosis of low back pain and/or radicular pain associated to spinal instability
Diagnosis of low back pain and/or radicular pain associated to degenerative disc disease
Elective single level surgery
Signed informed consent form

Exclusion Criteria:

Previous surgery with complete laminectomy, pars defect, etc
Patients that during the surgery requires complete laminectomy at level of the surgery
Structural lesion to facet joints
Osteoporosis
Systemic or local infection
Pregnant or planning to become pregnant