Dynesys Spinal System Post Market 522 Study



Status:Terminated
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:20 - 80
Updated:1/26/2019
Start Date:March 2012
End Date:April 2017

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Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.

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.

Study is meant to assess the safety and fusion rates following posterior lateral fusion with
the Dynesys Spinal System.

Inclusion Criteria:

1. Skeletally mature between the ages of 20-80

2. Candidate for posterior lateral fusion between T1-S1 with autograft

3. Degenerative spondylolisthesis with evidence of neurologic impairment or failed
previous fusion (pseudoarthrosis)

4. Symptoms of leg and/or back pain

5. Non-responsive to conservative/non-surgical treatment for at least three (3) months

6. Must be willing and able to comply with study requirements; including complete
necessary study paperwork and return for required follow-up visits

Exclusion Criteria:

1. Active systemic or local infection

2. Obesity

3. Use of interbody device

4. Pregnancy

5. Mental illness

6. Incarceration

7. Alcohol or drug abuse

8. Severe osteoporosis or osteopenia

9. Use in the cervical spine

10. Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and
polyethylene terephthalate

11. Soft tissue deficit not allowing sound closure

12. Any medical or physical condition that would preclude the potential benefit of spinal
implant surgery

13. Congenital abnormalities, tumors or other conditions that would prevent secure
component fixation that has the potential to decrease the useful life of the device

14. Active malignancy or other significant medical comorbidities

15. Any medical or mental condition which would put the patient at high risk due to the
severity of surgery

16. Inadequate pedicles of the thoracic, lumbar and sacral vertebrae

17. Patient unwilling or unable to follow postoperative instructions
We found this trial at
9
sites
6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Principal Investigator: Reginald Davis, M.D.
Phone: 443-849-4282
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Baltimore, Maryland 21229
Principal Investigator: Charles Schnee
Phone: 410-646-0220
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Belleville, Illinois 62226
Principal Investigator: William Sprich, M.D.
Phone: 618-233-3330
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Belleville, IL
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Cincinnati, Ohio 45242
Principal Investigator: Jonathan Borden, M.D.
Phone: 513-865-1148
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Cincinnati, OH
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Danville, Virginia 24541
Principal Investigator: Leon Abram
Phone: 434-793-4711
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Danville, VA
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New York, New York 10016
Principal Investigator: Themistocles Propopsaltis
Phone: 646-794-8643
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New York, NY
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: William Sprich, MD
Phone: 215-829-6720
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Willow Grove, Pennsylvania 19090
Principal Investigator: Michael Gratch
Phone: 267-913-3121
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Willow Grove, PA
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