Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection
Withdrawn before enrolling · Not applicable
Conditions studied: Kyphosis
In brief
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 kyphosis (PJK) caused by the accelerated degeneration of the joint capsules and smaller articular processes in the proximal junctional region has also been noted. One potential way of decreasing PJK is to decrease the structural rigidity of the construct at the top thereby providing a transition to the non-instrumented spine and allowing for less facet capsule and muscle disruption.
Key facts
- Study ID
- NCT01441999
- Run by
- Globus Medical Inc
- People needed
- 0
- Starts
- 2011-10-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2019-08-02
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Peachtree Neurosurgery — Atlanta, Georgia, United States
- Department of Neurosurgery, University of Michigan — Ann Arbor, Michigan, United States
- Department of Orthopedic Surgery, University of Copenhagen, Denmark — Copenhagen, Denmark
Full record on ClinicalTrials.gov
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