Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)

Status: Recruiting
Study State Date: November 2009
Primary Completion Date: Anticipated November 2012
Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase: Phase 4

Sponsor(s):
Lanx, Inc.
 
Information By: Lanx, Inc.
Trial Identifier: NCT01016314
Official Title: A Multi-Center Prospective Randomized Study to Evaluate the Efficacy of the Aspen Spinous Process System for Use in Anterior Lumbar Interbody Fusion (ALIF)

Description:  This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) treated with ALIF and supplemental posterior fixation using ASPEN Spinous Process System compared to pedicle screw instrumentation.

Accepts Healthy Volunteers?: No
Enrollment: 156 Anticipated
Minimum Age: 18 Years
Maximum Age: 75 Years
Gender(s): Both
Additional Criteria:  Inclusion Criteria: - Age between 18 and 75 years - Scheduled for an elective single level ALIF with posterior fixation - Diagnosis of primary symptomatic DDD confirmed with appropriate imaging studies and/or positive lumbar discography - Oswestry Disability Index (ODI) v 2.1 score >30% - Failed at least 6 weeks of conservative care (non-surgical)/clinical signs of neurological deterioration - No contraindications for ASPEN spinous process system (at the discretion of the investigator) Exclusion Criteria: - Prior lumbar fusion surgery at any level (prior discectomy and/or laminectomy allowed) - Spondylolisthesis grade 3 or more - Lytic spondylolisthesis - Incompetent or missing posterior arch at the affected level (e.g. laminectomy, pars defect) - Currently requires laminectomy at level of surgery - Facet joints at implant level are absent or fractured - Post-traumatic vertebral body compromise or acute fracture at implant level - Body mass Index (BMI) > 40 - Known allergy to titanium - Osteoporosis: SCORE (Simple Calculated Osteoporosis Risk Estimation) will be used to screen subjects who require DEXA. Subjects with T-score < -2.5 will be excluded - Paget's disease, osteomalacia, or any other metabolic bone disease - Use of medications or any drug known to potentially interfere with bone/soft tissue healing (e.g. chronic systemic steroids) - Planned use of Bone Morphogenetic Protein (BMP) - Unlikely to comply with the follow-up evaluation schedule - Subject has recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation - Participation in a clinical trial of another investigational drug or device within the past 30 days - Systemic infection such as AIDS, HIV, and active hepatitis - Active malignancy defined as history of invasive malignancy, except if the subject has received treatment and displayed no clinical signs and symptoms for at least five years - Pregnant or planning to become pregnant during the length of study participation - Involvement in active litigation related to back problems at the time of screening - Direct involvement in the execution of this protocol

Conditions:
Degenerative Disc Disease
Intervertebral Disk Degeneration
Interventions:
Device: Aspen Spinous Process System
Device: Pedicle Screw Fixation
 
Primary Outcome Measures:
Oswestry Disability Index (ODI)
Time Frame: 2 years
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

Aspen Spinous Process System: Experimental
Device: Aspen Spinous Process System
Aspen Spinous Process System is an interspinous process fixation device

 
Pedicle Screw Fixation: Active Comparator
Device: Pedicle Screw Fixation
Pedicle Screws are used for the fixation of the spine

 

Contacts:
Pam E Snyder 303-501-8394 pam.snyder@lanx.com



Study Locations:
+ Show All 5 Study Locations


United States, California
Pomona Valley Hospital Medical Center (Recruiting)
Pomona, California, United States
Contact: Kaushal Bhatt 909-397-0869 

University of California, Davis (Recruiting)
Sacramento, California, United States
Contact: Martha Robinson, RN 916-734-6511 



United States, Kansas
Kansas University Medical Center (Recruiting)
Kansas City, Kansas, United States
Contact: Joan McMahon, RN 913-588-7587 



United States, New York
New York University School of Medicine (Recruiting)
New York, New York, United States
Contact: Alexandra Lee, RN, CCRC 646-794-8643 



United States, Texas
South Texas Spine (Recruiting)
San Antonio, Texas, United States
Contact: Mary Tamez 210-614-6432 mtamez@spinaldoc.com

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