Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion

A Multi-Center Prospective Randomized Study Comparing Supplemental Posterior Instrumentation, Aspen™ Spinous Process System Versus Pedicle Screw Fixation, in Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

The purpose of this clinical investigation is to evaluate the Aspen™ device compared to pedicle screw instrumentation for posterior fixation in the treatment of patients with degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of fusion.

Study Overview

• Status: Completed
• Conditions: Degeneration of Lumbar Intervertebral Disc
• Intervention / Treatment: Device: Aspen Spinous Process Fixation Device; Device: Pedicle Screws

Detailed Description

This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and/or spondylolisthesis utilizing either Aspen Spinous Process Fixation System or Pedicle Screws for supplemental posterior instrumentation as an adjunct to an anterior or lateral approach to lumbar interbody fusion.

The primary hypothesis is that change in Oswestry Disability Index (ODI) of subjects in the study group (Aspen) will be non-inferior to the control group (pedicle screw instrumentation). The non-inferiority margin is pre-specified to be 10 ODI score points. If the non-inferiority is established, superiority of Aspen to the control will be tested.

The study will involve up to 25 investigational sites. Enrollment is expected to take approximately 24 months. Subjects will be followed for 2 years, with the anticipated duration of the study being approximately 4 years from start to finish.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Paducah, Kentucky, United States, 42001
      • Clint Hill
  • New York
    • Lockport, New York, United States, 14094
      • Buffalo Spine Surgery
  • Oregon
    • Medford, Oregon, United States, 97504
      • Andy Kranenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 75 years
• Scheduled for an elective single-level circumferential lumbar fusion by means of supplemental posterior fusion with fixation (allowing for the placement of ASPEN or pedicle screws) for an anterior or lateral interbody fusion
• Diagnosis of primary symptomatic Degenerative Disc Disease (DDD) and/or spondylolisthesis confirmed with appropriate imaging studies and/or positive lumbar discography
• Oswestry Disability Index (ODI) v2.1 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:

• Previous fusion at the operative level
• Spondylolisthesis Grade 3 or more
• 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: Simple Calculated Osteoporosis Risk Estimation (S.C.O.R.E.) > 6 AND Dual-energy X-ray absorptiometry (DEXA) T-score < -2.5
• 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)
• Planned use of Bone Morphogenetic Protein (BMP) for posterolateral fusion*
• 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
• Subject is a prisoner
• 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
• Pre-existing conditions that could interfere with the evaluation of outcome measures (e.g. musculoskeletal, neuromuscular, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aspen Spinous Process Fixation Device; Subjects randomized to the Aspen study arm will have the Aspen device implanted as supplemental posterior fixation only and according to the manufacturer's recommendations.	Device: Aspen Spinous Process Fixation Device; The Aspen device will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
Active Comparator: Pedicle Screws; Subjects randomized to the pedicle screw group will have polyaxial top loading pedicle screws implanted according to the standard procedures and practices at that institution. The procedure may be performed according to surgeon preference, including a traditional open, minimally invasive or percutaneous approach. Only pedicle screws cleared by FDA for this indication will be used in this study.	Device: Pedicle Screws; Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

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	Time Frame
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
Fusion success	12 months and 24 months
Neurological status	Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in SF-36	Baseline, 12 months & 24 months
Change in Visual Analogue Scale (VAS) (pain)	Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Operative parameters (estimate blood loss, fluor time, length of hospital stay)	Intraoperative

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Principal Investigator: Patel, University of Colorado, Denver; Principal Investigator: Cappuccino, Buffalo Spine Surgery

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: February 29, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 9, 2012

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: ASP-11-001

Plan for Individual participant data (IPD)

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