Status:
TERMINATED
Dynesys Spinal System Post Market 522 Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Degenerative Spondylolisthesis
Pseudoarthrosis
Eligibility:
All Genders
20-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- Active systemic or local infection
- Obesity
- Use of interbody device
- Pregnancy
- 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
- Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device
- Active malignancy or other significant medical comorbidities
- Any medical or mental condition which would put the patient at high risk due to the severity of surgery
- Inadequate pedicles of the thoracic, lumbar and sacral vertebrae
- Patient unwilling or unable to follow postoperative instructions
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01528072
Start Date
March 1 2012
End Date
April 1 2017
Last Update
January 29 2020
Active Locations (9)
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1
Neurological Surgery of Southern Ill
Belleville, Illinois, United States, 62226
2
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
3
Pine Heights Medical Center
Baltimore, Maryland, United States, 21229
4
NYU - Center for Musculoskeletal Care
New York, New York, United States, 10003