Clinical trial NCT01528072: Dynesys Spinal System Post Market 522 Study
Official title: Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Spondylolisthesis
Pseudoarthrosis
Keywords: Dynesys Dynamic Stabilization System
Spondylolithesis
pseudoarthrosis
neurologic impairment
failed fusion
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 153
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Fusion Rates
timeFrame: 24 months post surgery date
Secondary outcomes:
Other outcomes:
Locations:
city: Belleville
country: United States
facility: Neurological Surgery of Southern Ill
state: Illinois
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Pine Heights Medical Center
state: Maryland
city: New York
country: United States
facility: NYU - Center for Musculoskeletal Care
state: New York
city: Cincinnati
country: United States
facility: Riverhills Healthcare, Inc
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Willow Grove
country: United States
facility: OrthopaediCare
state: Pennsylvania
city: Danville
country: United States
facility: Danville Orthopedics and Spine
state: Virginia
Study officials:
affiliation: Zimmer Biomet Spine
name: Joel Batts
role: STUDY_DIRECTOR
References: