Dynesys Spinal System Post Market 522 Study

Stopped early · Not applicable

Conditions studied: Degenerative Spondylolisthesis, Pseudoarthrosis

In brief

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.

Key facts

Study ID

NCT01528072

Run by

Zimmer Biomet

People needed

153

Starts

2012-03-01

Expected to finish

2017-04-01

Last updated by the study team

2020-01-29

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Neurological Surgery of Southern Ill — Belleville, Illinois, United States
• Greater Baltimore Medical Center — Baltimore, Maryland, United States
• Pine Heights Medical Center — Baltimore, Maryland, United States
• NYU - Center for Musculoskeletal Care — New York, New York, United States
• Riverhills Healthcare, Inc — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• OrthopaediCare — Willow Grove, Pennsylvania, United States
• Danville Orthopedics and Spine — Danville, Virginia, United States

Full record on ClinicalTrials.gov

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