Study Stopped
Terminated at request of FDA
Dynesys Spinal System Post Market 522 Study
Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion.
1 other identifier
interventional
153
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedResults Posted
Study results publicly available
January 29, 2020
CompletedJanuary 29, 2020
January 1, 2020
5.1 years
February 2, 2012
June 5, 2019
January 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fusion Rates
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.
24 months post surgery date
Study Arms (1)
Dynesys System
EXPERIMENTALAll 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.
Interventions
Eligibility Criteria
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Biometlead
Study Sites (9)
Neurological Surgery of Southern Ill
Belleville, Illinois, 62226, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Pine Heights Medical Center
Baltimore, Maryland, 21229, United States
NYU - Center for Musculoskeletal Care
New York, New York, 10003, United States
Riverhills Healthcare, Inc
Cincinnati, Ohio, 45242, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19106, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
OrthopaediCare
Willow Grove, Pennsylvania, 19090, United States
Danville Orthopedics and Spine
Danville, Virginia, 24541, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination lead to a significant subset of subjects to not make it to the final follow up time interval. This resulted in small numbers of subjects analyzed for fusion and literature control was not used as planned originally in protocol.
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- Zimmer Biomet Spine
Study Officials
- STUDY DIRECTOR
Joel Batts
Zimmer Biomet Spine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2012
First Posted
February 7, 2012
Study Start
March 1, 2012
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
January 29, 2020
Results First Posted
January 29, 2020
Record last verified: 2020-01