Aspen Spinous Process Fixation System for Use in PLF in Patients With Spondylolisthesis

Stopped early

Conditions studied: Spondylolisthesis

In brief

The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.

Key facts

Study ID

NCT01560273

Run by

Zimmer Biomet

People needed

25

Starts

2012-02-01

Expected to finish

2015-09-01

Last updated by the study team

2019-01-09

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 50 and older
• Diagnosis of mild segmental instability on standing radiography lateral film defined as degenerative spondylolisthesis ≤ 4mm in dynamic imaging (i.e., flexion/extension)
• Scheduled for an elective single-level posterior decompression and posterolateral fusion using AspenTM spinous process fixation system
• Oswestry Disability Index (ODI) v 2.1 score >30%
• Failed at least 3 months of conservative care (non-surgical) OR has clinical signs of neurological deterioration
• Signed Informed Consent Form

You may not qualify if…

• Pre-operative
• Marked degenerative spondylolisthesis (>4mm)
• Lesions requiring surgery involving two levels
• Prior surgery at index level or adjacent level
• Prior spinal fusion surgery
• Isthmic or lytic spondylolisthesis
• Incompetent or missing posterior arch at the affected level (e.g. complete laminectomy, pars defect)
• Requires complete laminectomy at level of surgery
• Facet joints at implant level are absent or fractured
• Vertebral body compromise or acute fracture at implant level
• Body mass Index (BMI) ≥ 35
• Known allergy to titanium
• Osteoporosis: SCORE (Simple Calculated Osteoporosis Risk Estimation) will be used to screen subjects requiring 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 additional segmental fixation (eg. facet screws, anterior/lateral plating, anchored cages)
• Use of Bone Morphogenetic Protein (BMP)*
• Unlikely to comply with the follow-up evaluation schedule
• In the opinion of the Investigator, Subject has history of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation
• Active participation in a clinical trial of another drug or device
• Active systemic infection or any other health condition that would preclude surgery
• 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 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

• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Community Orthopedic Medical Group — Mission Viejo, California, United States
• Goodman Campbell Brian and Spine — Indianapolis, Indiana, United States
• Buffalo Spine Surgery — Lockport, New York, United States
• Pacific Spine Specialists — Tualatin, Oregon, United States

Full record on ClinicalTrials.gov

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