Dynesys Spinal System Post Market 522 Study

Not Applicable

Terminated

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.

Recruitment & Eligibility

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
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

Arm && Interventions

Group	Intervention	Description
Dynesys System	Dynesys Spinal System	All patients will receive the Dynesys System and all patients will be compared to historical literature control. Dynesys Spinal System will be used for all subjects.

Primary Outcome Measures

Name	Time	Method
Fusion Rates	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.

Secondary Outcome Measures

Name	Time	Method

Locations (9): Greater Baltimore Medical Center
🇺🇸
Baltimore, Maryland, United States
Neurological Surgery of Southern Ill
🇺🇸
Belleville, Illinois, United States
Riverhills Healthcare, Inc
🇺🇸
Cincinnati, Ohio, United States
NYU - Center for Musculoskeletal Care
🇺🇸
New York, New York, United States
Pine Heights Medical Center
🇺🇸
Baltimore, Maryland, United States
University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Danville Orthopedics and Spine
🇺🇸
Danville, Virginia, United States
OrthopaediCare
🇺🇸
Willow Grove, Pennsylvania, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States