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Aspen Spinous Process Fixation System for Use in PLF in Patients With Spondylolisthesis

This study has been terminated.
(Will answer study question through other research means.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560273
First Posted: March 22, 2012
Last Update Posted: March 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
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.

Condition Intervention Phase
Spondylolisthesis Device: Aspen Spinous Process Fixation Device Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Center Prospective Study Evaluation Aspen Spinous Process Fixation System for Use in Posterolateral Fusion (PLF) in Patients With Spondylolisthesis

Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Absolute change in Oswestry Disability Index (ODI) [ Time Frame: baseline to 12 months post-operative ]

Secondary Outcome Measures:
  • Title: Fusion success [ Time Frame: 12 Months post-operative ]
  • Change in Visual Analogue Scale (VAS) (pain) [ Time Frame: Baseline, 6 weeks, 2 weeks, 3 months, 6 months, 12 months, & 24 months ]
  • Neurological status [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months ]
    motor functions, reflexes, and sensory

  • Operative parameters (estimate blood loss, surgery time, fluoroscopy time, and length of hospital stay) [ Time Frame: Surgical Visit ]
  • Pain medication usage [ Time Frame: Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months ]
  • Change in EQ-5D-3L [ Time Frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months ]
  • Change in Zurich Claudication Questionnaire [ Time Frame: Baseline, 12 months & 24 months ]

Enrollment: 25
Study Start Date: February 2012
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aspen Spinous Process Fixation Device
The Aspen device provides supplemental posterior fixation for fusion
Device: Aspen Spinous Process Fixation Device
The Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF)

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 50 years and older with spondylolisthesis requiring a single level posterolateral decompression and posterolateral fusion
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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)
  • Planned use of additional segmental fixation (eg. facet screws, anterior/lateral plating, anchored cages)
  • Use of Bone Morphogenetic Protein (BMP)*
  • 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
  • Pregnant or planning to become pregnant during 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.)

Intra-operative Exclusion

  • Intra-operative visualization of a > 4mm spondylolisthesis not previously noted radiographically
  • Any change in the surgical procedure that violates the inclusion/exclusion criteria. (eg. switching to double level procedure; placing pedicle screws as posterior fixation).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560273


Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Community Orthopedic Medical Group
Mission Viejo, California, United States, 92691
United States, Indiana
Goodman Campbell Brian and Spine
Indianapolis, Indiana, United States, 47905
United States, New York
Buffalo Spine Surgery
Lockport, New York, United States, 14094
United States, Oregon
Pacific Spine Specialists
Tualatin, Oregon, United States, 97062
Sponsors and Collaborators
Zimmer Biomet
Investigators
Principal Investigator: Shah Goodman Campbell brain and Spine
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT01560273     History of Changes
Other Study ID Numbers: ASP-11-002
First Submitted: March 15, 2012
First Posted: March 22, 2012
Last Update Posted: March 15, 2016
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases