NCT01560273

Brief Summary

The purpose of this clinical investigation is to evaluate the clinical outcomes of subject with spondylolisthesis undergoing posterolateral fusion (PLF) surgery utilizing the Aspen™ Spinous Process Fixation System. The Aspen™ device will be evaluated using Oswestry Disability Index (ODI) improvement and success of fusion.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
terminated

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

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

3.6 years

First QC Date

March 15, 2012

Last Update Submit

January 8, 2019

Conditions

Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

  • Absolute change in Oswestry Disability Index (ODI)

    baseline to 12 months post-operative

Secondary Outcomes (7)

  • Title: Fusion success

    12 Months post-operative

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

    Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months

  • Neurological status

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

  • Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay)

    Surgical Visit

  • Pain medication usage

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

  • +2 more secondary outcomes

Study Arms (1)

Aspen Spinous Process Fixation Device

The Aspen device provides supplemental posterior fixation for fusion

Device: Aspen Spinous Process Fixation Device

Interventions

Aspen Spinous Process Fixation DeviceDEVICE

The Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF)

Aspen Spinous Process Fixation Device

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 50 years and older with spondylolisthesis requiring a single level posterolateral decompression and posterolateral fusion

You may qualify if:

  • Age between 50 and older
  • Diagnosis of mild segmental instability on standing radiography lateral film defined as degenerative spondylolisthesis ≤ 4mm in dynamic imaging (i.e., flexion/extension)
  • Scheduled for an elective single-level posterior decompression and posterolateral fusion using AspenTM spinous process fixation system
  • Oswestry Disability Index (ODI) v 2.1 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:

  • Pre-operative
  • Marked degenerative spondylolisthesis (\>4mm)
  • Lesions requiring surgery involving two levels
  • Prior surgery at index level or adjacent level
  • Prior spinal fusion surgery
  • Isthmic or 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: SCORE (Simple Calculated Osteoporosis Risk Estimation) will be used to screen subjects requiring 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)
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Community Orthopedic Medical Group

Mission Viejo, California, 92691, United States

Location

Goodman Campbell Brian and Spine

Indianapolis, Indiana, 47905, United States

Location

Buffalo Spine Surgery

Lockport, New York, 14094, United States

Location

Pacific Spine Specialists

Tualatin, Oregon, 97062, United States

Location

MeSH Terms

Conditions

Spondylolisthesis

Condition Hierarchy (Ancestors)

SpondylolysisSpondylosisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Shah

    Goodman Campbell brain and Spine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2012

First Posted

March 22, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 9, 2019

Record last verified: 2019-01

Locations

US(5)