Clinical trial NCT00791180: Posterior Lateral Fusion (PLF) With Dynesys
Official title: Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylolisthesis
Keywords: dynamic stabilization
Dynesys
fusion success
Immobilization of spinal segments as an adjunct to fusion in the treatment of the following:
acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine
degenerative spondylolisthesis with objective evidence of neurologic impairment
failed previous fusion (pseudarthrosis).
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-11-14
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical outcomes following postierior lateral fusion with the Dynesys(R) Spinal System

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical Outcomes
timeFrame: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months
Secondary outcomes:
measure: Surgical Outcomes
timeFrame: Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Foundation Surgical Hospital
state: Texas
Study officials:
affiliation: Zimmer Spine
name: Jozef Murar, M.D.
role: STUDY_DIRECTOR
References: