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

This study is currently recruiting participants.
Verified November 2013 by Biomet, Inc.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT01549366
First received: February 29, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Degenerative Disc Disease (DDD)
Device: Aspen Spinous Process Fixation Device
Device: Pedicle Screw Fixation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Absolute change in Oswestry Disability Index (ODI) [ Time Frame: baseline to 12 months post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fusion success [ Time Frame: 12 Months post-operative ] [ Designated as safety issue: No ]
  • Neurological status [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months ] [ Designated as safety issue: No ]
  • Change in EQ-5D-3L [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months ] [ Designated as safety issue: No ]
  • Change in SF-36 [ Time Frame: Baseline, 12 months & 24 months ] [ Designated as safety issue: No ]
  • Change in Visual Analogue Scale (VAS) (pain) [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months ] [ Designated as safety issue: No ]
  • Change in Zurich Claudication Questionnaire [ Time Frame: Baseline, 12 months & 24 months ] [ Designated as safety issue: No ]
  • Pain medication usage [ Time Frame: Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months ] [ Designated as safety issue: No ]
  • Operative parameters (estimate blood loss, fluor time, length of hospital stay) [ Time Frame: Surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspen Spinous Process Fixation Device
The Aspen device provides supplemental posterior fixation for fusion
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
Pedicle Screws provide supplemental posterior fixation for fusion
Device: Pedicle Screw Fixation
Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

  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 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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01549366

Contacts
Contact: Joel Batts 303-501-8583 Joel.Batts@lanx.com

Locations
United States, Kentucky
Clint Hill Recruiting
Paducah, Kentucky, United States, 42001
Principal Investigator: Clint Hill, MD         
United States, New York
Buffalo Spine Surgery Recruiting
Lockport, New York, United States, 14094
Principal Investigator: Andrew Cappuccino, MD         
United States, Oregon
Andy Kranenburg Recruiting
Medford, Oregon, United States, 97504
Principal Investigator: Andy Kranenburg, MD         
Sponsors and Collaborators
Biomet, Inc.
Investigators
Principal Investigator: Patel University of Colorado, Denver
Principal Investigator: Taylor University of California, San Diego
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT01549366     History of Changes
Other Study ID Numbers: ASP-11-001
Study First Received: February 29, 2012
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014