Posterior Lateral Fusion (PLF) With Dynesys

NCT00791180 | Completed

• 1 other identifier: 2006-002
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

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).

Outcome Measures

Primary Outcomes (1)

• Clinical Outcomes

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

Secondary Outcomes (1)

• Surgical Outcomes

  Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical outcomes following postierior lateral fusion with the Dynesys(R) Spinal System

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Foundation Surgical Hospital

Houston, Texas, 77074, United States

Location

MeSH Terms

Conditions

Spondylolisthesis; Pseudarthrosis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Study Officials

• Jozef Murar, M.D.

  Zimmer Spine

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: March 1, 2006
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 29, 2011

Record last verified: 2011-09

Locations

US (1)