Posterior Lateral Fusion (PLF) With Dynesys

• ClinicalTrials.gov Identifier: NCT00791180
• Recruitment Status: Completed
• First Posted: November 14, 2008
• Last Update Posted: September 29, 2011
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

Study Description

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.

Condition or disease
Spondylolisthesis

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 38 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Outcomes Following Posterior Lateral Fusion With the Dynesys(R) Spinal System
• Study Start Date: March 2006
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Clinical Outcomes [ Time Frame: Pre-op, Surgery, 3 month, 6 month, 12 months and 24 months ]

Secondary Outcome Measures :

1. Surgical Outcomes [ Time Frame: Pre-op, Surgery, 3 months, 6 months, 12 months and 24 months ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

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

Contacts and Locations

Locations

United States, Texas

Foundation Surgical Hospital

Houston, Texas, United States, 77074

Sponsors and Collaborators

Zimmer Biomet

Investigators

• Study Director: Jozef Murar, M.D.; Zimmer Spine

More Information

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT00791180
• Other Study ID Numbers: 2006-002
• First Posted: November 14, 2008
• Last Update Posted: September 29, 2011
• Last Verified: September 2011

Keywords provided by Zimmer Biomet:

• 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).

Additional relevant MeSH terms:

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