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

A Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis

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.

Study Overview

• Status: Terminated
• Conditions: Spondylolisthesis
• Intervention / Treatment: Device: Aspen Spinous Process Fixation Device

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center
  • California
    • Mission Viejo, California, United States, 92691
      • Community Orthopedic Medical Group
  • Indiana
    • Indianapolis, Indiana, United States, 47905
      • Goodman Campbell Brian and Spine
  • New York
    • Lockport, New York, United States, 14094
      • Buffalo Spine Surgery
  • Oregon
    • Tualatin, Oregon, United States, 97062
      • Pacific Spine Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 50 years and older with spondylolisthesis requiring a single level posterolateral decompression and posterolateral fusion

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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
• Pre-existing conditions that could interfere with the evaluation of outcome measures (e.g. musculoskeletal, neuromuscular, etc.)

Intra-operative Exclusion

• Intra-operative visualization of a > 4mm spondylolisthesis not previously noted radiographically
• Any change in the surgical procedure that violates the inclusion/exclusion criteria. (eg. switching to double level procedure; placing pedicle screws as posterior fixation).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aspen Spinous Process Fixation Device; The Aspen device provides supplemental posterior fixation for fusion	Device: Aspen Spinous Process Fixation Device; The Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute change in Oswestry Disability Index (ODI)	baseline to 12 months post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Title: Fusion success		12 Months post-operative
Change in Visual Analogue Scale (VAS) (pain)		Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months
Neurological status	motor functions, reflexes, and sensory	Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay)		Surgical Visit
Pain medication usage		Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in EQ-5D-3L		Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in Zurich Claudication Questionnaire		Baseline, 12 months & 24 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Shah, Goodman Campbell Brain and Spine

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 15, 2012
• First Submitted That Met QC Criteria: March 20, 2012
• First Posted (Estimate): March 22, 2012

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: ASP-11-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided