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

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

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Degenerative Spondylolisthesis
• Intervention / Treatment: Device: SpineLink® , SpineLink® II

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.

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • Alvarado Orthopedic Clinic
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Rogozinski Orthopedic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Multiple site around the US

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SpineLink® , SpineLink® II Group; Spinal fusion surgery with SpineLink®	Device: SpineLink® , SpineLink® II; Spine plate system for lumbar spinal fusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurologic Assessment	Maintenance or Improvement	24 Months
Radiographic Fusion Grade	Radiographic fusion grade will be assessed at each follow up, as defined by Dawson et al. 8, as follows: A0 = Pseudarthrosis A1 = Unilateral Pseudarthrosis A2 = Insufficient Unilateral Bone Mass A3 = Contiguous Fusion without Hypertrophy A4 = Solid Fusion with Hypertrophy of Fusion Mass	24 Months
SF-36 Health Survey	Health Survey	24 Months

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: May 1, 2000
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): November 1, 2009

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (ESTIMATE): July 31, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Spondylolisthesis; Instability
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Spondylolisthesis
• Other Study ID Numbers: CS-044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED