A Multicenter Prospective Patient Outcome Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability
This study has been completed.
Information provided by (Responsible Party):
Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
First received: July 29, 2008
Last updated: February 13, 2012
Last verified: February 2012
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.
Degenerative Disc Disease
Device: SpineLink® , SpineLink® II
||Observational Model: Case-Only
Time Perspective: Prospective
||A Multicenter Prospective Patient Outcome Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2009 (Final data collection date for primary outcome measure)
Spinal fusion surgery with SpineLink®
Device: SpineLink® , SpineLink® II
Spine plate system for lumbar spinal fusions
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Multiple site around the US
- 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.
- This surgery will be the primary fusion attempt with no more than three (3) vertebrae or 2 disc spaces involved.
- The patient must be available for yearly follow-up in the study until completion of the 24 month evaluation.
- The patient must be skeletally mature (epiphyses closed).
- Bone grafting material must be limited to autograft and/or bone-bank allograft.
- The patient must be willing to comply with the treatment regimen, follow-up requirements, and have the legal ability to give informed consent.
- 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).
- Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc.
- Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc.
- Patients who have significant metabolic diseases including insulin dependent diabetes, renal dysfunction, etc.
- Patients involved in personal injury litigation.
- Pregnant or nursing females.
- Patient in whom unapproved biologicals (e.g. BMP-2) or bone substitute materials (e.g. Grafton) would be used at the fusion site.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00726310
|Alvarado Orthopedic Clinic
|San Diego, California, United States, 92120 |
|Rogozinski Orthopedic Clinic
|Jacksonville, Florida, United States, 32216 |
EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
||John Evangelsita, MD
||EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
No publications provided
||Biomet, Inc. ( EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 29, 2008
||February 13, 2012
||United States: Institutional Review Board
Keywords provided by Biomet, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Intervertebral Disk Degeneration