Status:
WITHDRAWN
Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection
Lead Sponsor:
Globus Medical Inc
Collaborating Sponsors:
University of Michigan
Polaris Spine and Neurosurgery Center
Conditions:
Kyphosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The treatment of adult deformity has improved with the development and use of modern segmental instrumentation, including posterior instrumentation. However, the incidence of proximal junctional kypho...
Detailed Description
While a possible solution to PJK is to reduce structural rigidity at the top of the construct, there is a need to investigate it. In the proposed study, the investigators will compare the rate of prox...
Eligibility Criteria
Inclusion
- Adult patients with degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis) requiring treatment with an instrumented posterior fusion from the thoracolumbar junction (T10-L1) to the sacrum
- At least 18 years of age and maximum 70 years of age
- Ability to provide Informed Consent for study participation and patients to return for all follow-up visits
Exclusion
- Presence of systemic or localized infection
- Previous fusion attempt at the involved level(s)
- More than three previous open, posterior, lumbar spinal surgical procedures at the involved level(s)
- Trauma at the levels to be fused
- Previous documentation of osteopenia or osteomalacia
- Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.)
- Immunosuppressive disorder
- Pregnancy
- History of alcohol and/or drug abuse
- Any known allergy to a metal alloy
- Mentally incompetent or prisoner
- Currently a participant in another study
- Preoperative structural deformity in the thoracic spine (kyphosis \>60 degrees, Coronal curve \>40 degrees)
- Circumferential fusion above L1
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01441999
Start Date
October 1 2011
End Date
March 1 2017
Last Update
August 2 2019
Active Locations (3)
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1
Peachtree Neurosurgery
Atlanta, Georgia, United States, 30342
2
Department of Neurosurgery, University of Michigan
Ann Arbor, Michigan, United States, 48109-0338
3
Department of Orthopedic Surgery, University of Copenhagen, Denmark
Copenhagen, Denmark, 2100