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Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00726310
First Posted: July 31, 2008
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 open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system.

Condition Intervention
Degenerative Disc Disease Degenerative Spondylolisthesis Device: SpineLink® , SpineLink® II

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter Prospective Patient Outcome Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability

Resource links provided by NLM:


Further study details as provided by Zimmer Biomet:

Primary Outcome Measures:
  • Percentage of successful fusions achieved [ Time Frame: 24 Months ]

Secondary Outcome Measures:
  • Oswestry Questionnaire (%Change From Baseline), Neurologic Assessment (Maintenance or Improvement), Radiographic Fusion Grade, SF-36™ Health Survey (Change from Baseline) [ Time Frame: 24 Months ]

Enrollment: 205
Study Start Date: May 2000
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SpineLink® , SpineLink® II Group
Spinal fusion surgery with SpineLink®
Device: SpineLink® , SpineLink® II
Spine plate system for lumbar spinal fusions

Detailed Description:
This will be an open, prospective, multi-center outcome study. This study will be conducted at up to ten centers, each of which will enroll approximately 20 patients. A maximum of 200 patients will be enrolled. This patient sample size will allow statistical comparison to historical literature and allow an inter-center comparison of outcome. Enrollment into the study may include all patients who have lumbar spinal fusion performed. All spinal fusion surgery will be performed using the EBI SpineLink® system.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Multiple site around the US
Criteria

Inclusion Criteria:

  1. The patient has demonstrated Grade I or Grade II degenerative spondylolisthesis exhibited by maximum slippage on flexion and extension radiographs with symptoms that include back pain and/or leg pain with spinal fusion indicated, or spinal instability as evidenced by greater than 3 mm of translational motion or greater than 10 degrees of angular motion between the involved vertebrae as evidenced by flexion-extension radiographs.
  2. This surgery will be the primary fusion attempt with no more than three (3) vertebrae or 2 disc spaces involved.
  3. The patient must be available for yearly follow-up in the study until completion of the 24 month evaluation.
  4. The patient must be skeletally mature (epiphyses closed).
  5. Bone grafting material must be limited to autograft and/or bone-bank allograft.
  6. The patient must be willing to comply with the treatment regimen, follow-up requirements, and have the legal ability to give informed consent.

Exclusion Criteria:

  1. Patients with supplemental spinal internal fixation devices previously implanted at any other level and/or a previous fusion attempt at the involved level(s) (no interbody fusions, salvage procedures, or prior hardware).
  2. Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
  3. Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
  4. Patients who have significant metabolic diseases including insulin dependent diabetes, renal dysfunction, etc.
  5. Patients involved in personal injury litigation.
  6. Pregnant or nursing females.
  7. Patient in whom unapproved biologicals (e.g. BMP-2) or bone substitute materials (e.g. Grafton) would be used at the fusion site.
  8. Patients who are unable to understand and sign an informed consent or who, in the opinion of the investigator, would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unable to participate in the follow-up.
  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): NCT00726310


Locations
United States, California
Alvarado Orthopedic Clinic
San Diego, California, United States, 92120
United States, Florida
Rogozinski Orthopedic Clinic
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Zimmer Biomet
Investigators
Study Director: Hallie Murray Zimmer Biomet
  More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00726310     History of Changes
Other Study ID Numbers: CS-044
First Submitted: July 29, 2008
First Posted: July 31, 2008
Last Update Posted: March 15, 2016
Last Verified: February 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
Spondylolisthesis
Instability

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