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OpenTrials
Completed

NCT Number: NCT00791180

Posterior Lateral Fusion (PLF) With Dynesys

The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System. Secondary purpose of this study is to assess outcomes with historical controls along a continuum of motion and anatomy sparing procedures.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Foundation Surgical Hospital

Houston, Texas, 77074, United States

About this study

This study will help the patient to the extent that it will allow the comparison of this unique treatment to the corpus of literature on radicular pathology, thus focusing a specific treatment for a specific pathology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Spondylolisthesis of less than Grade II at the index level (degenerative with intact pars)
  • Will receive a decompression for lumbar stenosis
  • Symptoms of leg and/or back pain
  • One pathological level
  • Between the ages of 20 and 80 at the time of surgery
  • Non-responsive to non-surgical treatment for at least six months

Exclusion criteria

  • Osteolytic spondylolisthesis
  • Planned complete facetectomy
  • Two or more pathological levels (and as enumerated int he Dynesys Spinal system instructions for use)
  • Use in the cervical spine
  • Active systemic or local infection
  • Extreme obesity as defined by a Body Mass Index (BMI)over 40. BMI calculated using Appendix A, adapted from the National Heart, Lung, and Blood Institute, Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.
  • Pregnancy
  • Mental illness
  • Severe osteoporosis or osteopenia. The World Health Organization defines osteoporosis as BMD<-2.5t. Professional discretion should be used and if bone quality is in question a DEXA scan is recommended.
  • Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
  • Alcohol or drug abuse
  • Patient unwilling or unable to follow postoperative instructions
  • Soft tissue deficit not allowing sound closure
  • Any medical or physical condition that would preclude the potential benefit of spinal surgery
  • Inadequate pedicles of the lumbar or sacral vertebrae; congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of othe devices;
  • Any medical or mental condition which would exclude the patient at high risk from surgery of the severity

Treatment and study plan

Primary outcomes

  1. Clinical Outcomes

    Time frame: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months

Secondary outcomes

  1. Surgical Outcomes

    Time frame: Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months

Sponsors and collaborators

Lead sponsor

Zimmer Biomet

Industry

Registry information

Official study title

Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Nov 14, 2008
Registry last updated
Sep 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.