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

February 29, 2012
November 26, 2013
February 2012
December 2014   (final data collection date for primary outcome measure)
Absolute change in Oswestry Disability Index (ODI) [ Time Frame: baseline to 12 months post-operative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01549366 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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) [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Degenerative Disc Disease (DDD)
  • 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)
  • Device: Pedicle Screw Fixation
    Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
  • Active Comparator: Aspen Spinous Process Fixation Device
    The Aspen device provides supplemental posterior fixation for fusion
    Intervention: Device: Aspen Spinous Process Fixation Device
  • Active Comparator: Pedicle Screws
    Pedicle Screws provide supplemental posterior fixation for fusion
    Intervention: Device: Pedicle Screw Fixation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
December 2015
December 2014   (final data collection date for primary outcome measure)

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.)
Both
18 Years to 75 Years
No
Contact: Joel Batts 303-501-8583 Joel.Batts@lanx.com
United States
 
NCT01549366
ASP-11-001
No
Biomet, Inc.
Biomet, Inc.
Not Provided
Principal Investigator: Patel University of Colorado, Denver
Principal Investigator: Taylor University of California, San Diego
Biomet, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP