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

This study is currently recruiting participants. (see Contacts and Locations)
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: September 10, 2014
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
Degeneration of Lumbar Intervertebral Disc
Device: Aspen Spinous Process Fixation Device
Device: Pedicle Screws
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
Experimental: Aspen Spinous Process Fixation Device
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 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
Subjects randomized to the pedicle screw group will have polyaxial top loading 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 Screws
Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

Detailed Description:

This is a multi-center, prospective randomized clinical study to evaluate the clinical outcome of subjects with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and/or spondylolisthesis utilizing either Aspen Spinous Process Fixation System or Pedicle Screws for supplemental posterior instrumentation as an adjunct to an anterior or lateral approach to lumbar interbody fusion.

The primary hypothesis is that change in Oswestry Disability Index (ODI) of subjects in the study group (Aspen) will be non-inferior to the control group (pedicle screw instrumentation). The non-inferiority margin is pre-specified to be 10 ODI score points. If the non-inferiority is established, superiority of Aspen to the control will be tested.

The study will involve up to 25 investigational sites. Enrollment is expected to take approximately 24 months. Subjects will be followed for 2 years, with the anticipated duration of the study being approximately 4 years from start to finish.

  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
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: 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: Cappuccino Buffalo Spine Surgery
  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: September 10, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014