NCT01016314

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

6.2 years

First QC Date

November 18, 2009

Last Update Submit

January 18, 2019

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index (ODI)

    2 years

Study Arms (2)

Aspen Spinous Process System

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 System

Pedicle Screw Fixation

ACTIVE COMPARATOR

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

Interventions

Aspen Spinous Process SystemDEVICE

Aspen Spinous Process System is an interspinous process fixation device

Aspen Spinous Process System
Pedicle Screw FixationDEVICE

Pedicle Screws are used for the fixation of the spine

Pedicle Screw Fixation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

South Texas Spine

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Kee Kim, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR
0

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

November 18, 2009

First Posted

November 19, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

US(5)