Dynesys Spinal System Post Market 522 Study
This study is currently recruiting participants.
Verified February 2013 by Zimmer, Inc.
Sponsor:
Zimmer, Inc.
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT01528072
First received: February 2, 2012
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Degenerative Spondylolisthesis Pseudoarthrosis |
Device: Dynesys Spinal System |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Post Market Surveillance for the Dynesys Spinal System, Assessing Safety and Fusion. |
Further study details as provided by Zimmer, Inc.:
Primary Outcome Measures:
- Fusion rates (fused or not fused) at all treated levels of spine. [ Time Frame: 24 months post surgery date ] [ Designated as safety issue: No ]
- Safety Endpoints and Evaluation [ Time Frame: 24-month ] [ Designated as safety issue: Yes ]Subjects will be clinically evaluated for adverse experiences and functional outcomes over the course of 24 months
| Estimated Enrollment: | 168 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dynesys System
All patients will receive the Dynesys System and all patients will be compared to historical literature control.
|
Device: Dynesys Spinal System
Dynesys Spinal System will be used for all subjects
|
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528072
Contacts
| Contact: Laura Herdrich | 952-830-6224 | laura.herdrich@zimmer.com |
| Contact: Joe Murar, M.D. | 952-836-8534 | joe.murar@zimmer.com |
Locations
| United States, Illinois | |
| Neurological Surgery of Southern Ill | Recruiting |
| Belleville, Illinois, United States, 62226 | |
| Contact: Sandy Reith, NP 618-233-3330 smreith@gmail.com | |
| Contact: Elizabeth Wallace, RN 618-233-3330 ewallace@memorialmedgroup.com | |
| Principal Investigator: William Sprich, M.D. | |
| United States, Maryland | |
| Greater Baltimore Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: Robin Perry, RN 443-849-4282 RPERRY@gbmc.org | |
| Principal Investigator: Reginald Davis, M.D. | |
| Pine Heights Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21229 | |
| Contact: Cynthia Ray 410-646-0220 hhschtd@hotmail.com | |
| Principal Investigator: Charles Schnee | |
| United States, Ohio | |
| Riverhills Healthcare, Inc | Recruiting |
| Cincinnati, Ohio, United States, 45242 | |
| Contact: Debbie Coughlin, RN 513-865-1148 deborah_coughlin@trihealth.com | |
| Principal Investigator: Jonathan Borden, M.D. | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Contact: Marie Kerr 215-829-6720 marie.kerr@upenn.edu | |
| Principal Investigator: William Sprich, MD | |
| Allegheny General Hospital | Recruiting |
| Pittsburg, Pennsylvania, United States, 15212 | |
| Contact: Diane Cantella 412-359-3353 dcantell@wpahs.com | |
| Principal Investigator: Donald Whiting, MD | |
Sponsors and Collaborators
Zimmer, Inc.
More Information
No publications provided
| Responsible Party: | Zimmer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01528072 History of Changes |
| Other Study ID Numbers: | CMU2010-10S |
| Study First Received: | February 2, 2012 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Zimmer, Inc.:
|
Dynesys Dynamic Stabilization System Spondylolithesis pseudoarthrosis neurologic impairment failed fusion |
Additional relevant MeSH terms:
|
Pseudarthrosis Spondylolisthesis Fractures, Ununited Fractures, Bone Wounds and Injuries |
Spondylolysis Spondylosis Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013