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

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ClinicalTrials.gov Identifier: NCT01016314
Recruitment Status : Active, not recruiting
First Posted : November 19, 2009
Last Update Posted : February 29, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Device: Aspen Spinous Process System Device: Pedicle Screw Fixation Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2009
Primary Completion Date : January 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Aspen Spinous Process System
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 System
Aspen Spinous Process System is an interspinous process fixation device
Active Comparator: Pedicle Screw Fixation
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.
Device: Pedicle Screw Fixation
Pedicle Screws are used for the fixation of the spine

Outcome Measures

Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 2 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016314

United States, California
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
University of California, Davis
Sacramento, California, United States, 95817
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
United States, Texas
South Texas Spine
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Zimmer Biomet
Principal Investigator: Kee Kim, MD University of California, Davis
More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01016314     History of Changes
Other Study ID Numbers: ASP-09-001
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases