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

Primary Purpose

Degeneration of Lumbar Intervertebral Disc

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspen Spinous Process Fixation Device
Pedicle Screws
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degeneration of Lumbar Intervertebral Disc

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Clint Hill
  • Buffalo Spine Surgery
  • Andy Kranenburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aspen Spinous Process Fixation Device

Pedicle Screws

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Absolute change in Oswestry Disability Index (ODI)

Secondary Outcome Measures

Fusion success
Neurological status
Change in EQ-5D-3L
Change in SF-36
Change in Visual Analogue Scale (VAS) (pain)
Change in Zurich Claudication Questionnaire
Pain medication usage
Operative parameters (estimate blood loss, fluor time, length of hospital stay)

Full Information

First Posted
February 29, 2012
Last Updated
March 5, 2018
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01549366
Brief Title
Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degeneration of Lumbar Intervertebral Disc

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspen Spinous Process Fixation Device
Arm Type
Experimental
Arm Description
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.
Arm Title
Pedicle Screws
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Aspen Spinous Process Fixation Device
Intervention Description
The Aspen device will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
Intervention Type
Device
Intervention Name(s)
Pedicle Screws
Intervention Description
Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
Primary Outcome Measure Information:
Title
Absolute change in Oswestry Disability Index (ODI)
Time Frame
baseline to 12 months post-operative
Secondary Outcome Measure Information:
Title
Fusion success
Time Frame
12 months and 24 months
Title
Neurological status
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Title
Change in EQ-5D-3L
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Title
Change in SF-36
Time Frame
Baseline, 12 months & 24 months
Title
Change in Visual Analogue Scale (VAS) (pain)
Time Frame
Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Title
Change in Zurich Claudication Questionnaire
Time Frame
Baseline, 12 months & 24 months
Title
Pain medication usage
Time Frame
Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Title
Operative parameters (estimate blood loss, fluor time, length of hospital stay)
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patel
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cappuccino
Organizational Affiliation
Buffalo Spine Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clint Hill
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
Buffalo Spine Surgery
City
Lockport
State/Province
New York
ZIP/Postal Code
14094
Country
United States
Facility Name
Andy Kranenburg
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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