Clinical trial NCT01441999: Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection
Official title: Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kyphosis
Keywords: Rigid rods
less rigid rods
prevent kyphosis
long constructs
Lead sponsor: Globus Medical Inc
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
name: Polaris Spine and Neurosurgery Center
First posted: 2011-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

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 proximal junctional kyphosis in patients treated with a stainless steel rod (REVERE Stabilization System) versus those treated with TRANSITION Stabilization System.

Patient outcome measures (Scoliosis Research Society (SRS-22), SF12 and ODI) and radiographic measurements (including lumbar lordosis (L1-S1), adjacent segment kyphosis, thoracolumbar kyphosis (T10-L2), sagittal balance, sacral slope, and pelvic incidence) will be analyzed.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits
timeFrame: 2 years
Secondary outcomes:
measure: Patient outcome measures
timeFrame: 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Peachtree Neurosurgery
state: Georgia
city: Ann Arbor
country: United States
facility: Department of Neurosurgery, University of Michigan
state: Michigan
city: Copenhagen
country: Denmark
facility: Department of Orthopedic Surgery, University of Copenhagen, Denmark
Study officials:
affiliation: Globus Medical Inc
name: Bryan Cunningham, PhD
role: STUDY_DIRECTOR
References:
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