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

NCT01549366 | Completed

• 1 other identifier: ASP-11-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Degeneration of Lumbar Intervertebral Disc

Outcome Measures

Primary Outcomes (1)

• Absolute change in Oswestry Disability Index (ODI)

  baseline to 12 months post-operative

Secondary Outcomes (8)

• Fusion success

  12 months and 24 months

• Neurological status

  Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months

• Change in EQ-5D-3L

  Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months

• Change in SF-36

  Baseline, 12 months & 24 months

• Change in Visual Analogue Scale (VAS) (pain)

  Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months

Study Arms (2)

Aspen Spinous Process Fixation Device

EXPERIMENTAL

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

Pedicle Screws

ACTIVE COMPARATOR

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

Interventions

Aspen Spinous Process Fixation Device DEVICE

The Aspen device will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

Aspen Spinous Process Fixation Device

Pedicle Screws DEVICE

Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)

Pedicle Screws

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (3)

Clint Hill

Paducah, Kentucky, 42001, United States

Location

Buffalo Spine Surgery

Lockport, New York, 14094, United States

Location

Andy Kranenburg

Medford, Oregon, 97504, United States

Location

MeSH Terms

Interventions

Pedicle Screws

Intervention Hierarchy (Ancestors)

Bone Screws; Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Patel

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Cappuccino

  Buffalo Spine Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 9, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

US (3)