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

Primary Purpose

Degenerative Disc Disease

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Withdrawn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

About this trial

This is an interventional treatment trial for Degenerative Disc Disease

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 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Pomona Valley Hospital Medical Center
  • University of California, Davis
  • Kansas University Medical Center
  • New York University School of Medicine
  • South Texas Spine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aspen Spinous Process System

Pedicle Screw Fixation

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 the 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

Oswestry Disability Index (ODI)

Secondary Outcome Measures

Full Information

First Posted
November 18, 2009
Last Updated
January 18, 2019
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT01016314
Brief Title
Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)
Official Title
A Multi-Center Prospective Randomized Study to Evaluate the Efficacy of the Aspen Spinous Process System for Use in Anterior Lumbar Interbody Fusion (ALIF)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Protocol amended to NCT01549366 and participants rolled into study
Study Start Date
November 2009 (Actual)
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
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.
Detailed Description
This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with DDD who are treated with ALIF and supplemental posterior fixation using Aspen compared to pedicle screw instrumentation. The study will involve up to approximately 25 investigational sites and enroll up to 156 67 subjects. The randomization ratio of two Aspen subjects to one pedicle screw subject (2:1) will be utilized. Subjects with lumbar DDD who are candidates for ALIF at a single level will be screened for inclusion in the study. If the subject meets all of the eligibility criteria, they will be enrolled and randomized to either the Aspen or pedicle screw group. Subjects will continue to be followed by the guidelines set forth in this clinical protocol, which include: a postoperative discharge exam; six week, three month, six month, and one year post-op visits; and, concludes with a two year post-op visit. The follow-up is counted from the day of surgery. The enrollment period is expected to be approximately 12 months and subjects will be followed for 2 years post-op for the duration of the clinical investigation. The anticipated duration of the study is approximated to be 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Aspen Spinous Process System
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 Screw Fixation
Arm Type
Active Comparator
Arm Description
Subjects randomized to the pedicle screw group will have the 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 System
Intervention Description
Aspen Spinous Process System is an interspinous process fixation device
Intervention Type
Device
Intervention Name(s)
Pedicle Screw Fixation
Intervention Description
Pedicle Screws are used for the fixation of the spine
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Time Frame
2 years

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 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kee Kim, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pomona Valley Hospital Medical Center
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
South Texas Spine
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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