A Multicenter Prospective Patient Outcome Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier:
NCT00726310
First received: July 29, 2008
Last updated: February 13, 2012
Last verified: February 2012
  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

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:
  • Percentage of successful fusions achieved [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
1
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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Investigators
Study Chair: John Evangelsita, MD EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
  More Information

No publications provided

Responsible Party: Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
ClinicalTrials.gov Identifier: NCT00726310     History of Changes
Other Study ID Numbers: CS-044
Study First Received: July 29, 2008
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Biomet, Inc.:
Spondylolisthesis
Instability

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

ClinicalTrials.gov processed this record on July 20, 2014