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

Withdrawn before enrolling · Not applicable

Conditions studied: Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT01016314

Run by

Zimmer Biomet

People needed

0

Starts

2009-11-01

Expected to finish

2016-01-01

Last updated by the study team

2019-01-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Pomona Valley Hospital Medical Center — Pomona, California, United States
• University of California, Davis — Sacramento, California, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• New York University School of Medicine — New York, New York, United States
• South Texas Spine — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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