Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Spondylolisthesis
- Sponsor
- Zimmer Biomet
- Enrollment
- 153
- Locations
- 9
- Primary Endpoint
- Fusion Rates
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
Detailed Description
Study is meant to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Skeletally mature between the ages of 20-80
- •Candidate for posterior lateral fusion between T1-S1 with autograft
- •Degenerative spondylolisthesis with evidence of neurologic impairment or failed previous fusion (pseudoarthrosis)
- •Symptoms of leg and/or back pain
- •Non-responsive to conservative/non-surgical treatment for at least three (3) months
- •Must be willing and able to comply with study requirements; including complete necessary study paperwork and return for required follow-up visits
Exclusion Criteria
- •Active systemic or local infection
- •Use of interbody device
- •Mental illness
- •Incarceration
- •Alcohol or drug abuse
- •Severe osteoporosis or osteopenia
- •Use in the cervical spine
- •Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and polyethylene terephthalate
- •Soft tissue deficit not allowing sound closure
- •Any medical or physical condition that would preclude the potential benefit of spinal implant surgery
Outcomes
Primary Outcomes
Fusion Rates
Time Frame: 24 months post surgery date
Fusion was defined by meeting three criteria: * rotation \< 5° between motion segments on flexion-extension radiographs * translation \< 3 mm between motion segments on flexion-extension radiographs * presence of bridging bone. Fusion assessment for each patient was categorized as one of the four defined outcomes: fused, not fused, partial fusion, or UA (unable to assess). Efficacy was confirmed by the achievement of fusion in the experimental group when compared to the rate established in a literature control.