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

NCT00726310 | Completed

• 1 other identifier: CS-044
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis

Keywords

Spondylolisthesis; Instability

Outcome Measures

Primary Outcomes (1)

• Percentage of successful fusions achieved

  AP radiographs will be evaluated for the evidence of bridging virgin trabecular bone across the fusion mass. In order for a patient to be considered fused, A/P radiographs must show evidence of bridging virgin trabecular bone across the fusion mass.

  24 Months

Secondary Outcomes (3)

• Neurologic Assessment

  24 Months

• Radiographic Fusion Grade

  24 Months

• SF-36 Health Survey

  24 Months

Study Arms (1)

SpineLink® , SpineLink® II Group

Spinal fusion surgery with SpineLink®

Device: SpineLink® , SpineLink® II

Interventions

SpineLink® , SpineLink® II DEVICE

Spine plate system for lumbar spinal fusions

SpineLink® , SpineLink® II Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Multiple site around the US

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Alvarado Orthopedic Clinic

San Diego, California, 92120, United States

Location

Rogozinski Orthopedic Clinic

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: July 31, 2008
• Study Start: May 1, 2000
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: February 13, 2020

Record last verified: 2020-02

Locations

US (2)