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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01016314
First received: November 18, 2009
Last updated: July 17, 2014
Last verified: December 2013
  Purpose

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 Intervention Phase
Degenerative Disc Disease
Device: Aspen Spinous Process System
Device: Pedicle Screw Fixation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Oswestry Disability Index (ODI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: November 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016314

Contacts
Contact: Brieta Bejin 303-501-8528 brieta.bejin@biomet.com

Locations
United States, California
Pomona Valley Hospital Medical Center Active, not recruiting
Pomona, California, United States, 91767
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Cheri Grelle    916-734-6517    cheri.grelle@ucdavismc.edu   
Principal Investigator: Kee Kim, MD         
United States, Kansas
Kansas University Medical Center Active, not recruiting
Kansas City, Kansas, United States, 66160
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Alexandra Lee, RN, CCRC    646-794-8643      
Principal Investigator: Peter Passias, M.D.         
Sub-Investigator: Alexander DeMoura, M.D.         
United States, Texas
South Texas Spine Active, not recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Kee Kim, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01016314     History of Changes
Other Study ID Numbers: ASP-09-001
Study First Received: November 18, 2009
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014