Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection
NCT ID: NCT01441999
Last Updated: 2019-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2011-10-31
2017-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Less rigid rods
Titanium rods that have a soft, plastic end
Less rigid rod
Titanium rod with semi rigid end
Rigid Rods
Titanium rods
Rigid Rod
Rigid Titanium rods
Interventions
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Less rigid rod
Titanium rod with semi rigid end
Rigid Rod
Rigid Titanium rods
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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University of Michigan
OTHER
Polaris Spine and Neurosurgery Center
OTHER
Globus Medical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Bryan Cunningham, PhD
Role: STUDY_DIRECTOR
Globus Medical Inc
Locations
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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
Countries
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References
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Glattes RC, Bridwell KH, Lenke LG, Kim YJ, Rinella A, Edwards C 2nd. Proximal junctional kyphosis in adult spinal deformity following long instrumented posterior spinal fusion: incidence, outcomes, and risk factor analysis. Spine (Phila Pa 1976). 2005 Jul 15;30(14):1643-9. doi: 10.1097/01.brs.0000169451.76359.49.
Hee HT, Yu ZR, Wong HK. Comparison of segmental pedicle screw instrumentation versus anterior instrumentation in adolescent idiopathic thoracolumbar and lumbar scoliosis. Spine (Phila Pa 1976). 2007 Jun 15;32(14):1533-42. doi: 10.1097/BRS.0b013e318067dc3d.
Hollenbeck SM, Glattes RC, Asher MA, Lai SM, Burton DC. The prevalence of increased proximal junctional flexion following posterior instrumentation and arthrodesis for adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 2008 Jul 1;33(15):1675-81. doi: 10.1097/BRS.0b013e31817b5bea.
Kim YJ, Bridwell KH, Lenke LG, Kim J, Cho SK. Proximal junctional kyphosis in adolescent idiopathic scoliosis following segmental posterior spinal instrumentation and fusion: minimum 5-year follow-up. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2045-50. doi: 10.1097/01.brs.0000179084.45839.ad.
Kim YJ, Lenke LG, Bridwell KH, Kim J, Cho SK, Cheh G, Yoon J. Proximal junctional kyphosis in adolescent idiopathic scoliosis after 3 different types of posterior segmental spinal instrumentation and fusions: incidence and risk factor analysis of 410 cases. Spine (Phila Pa 1976). 2007 Nov 15;32(24):2731-8. doi: 10.1097/BRS.0b013e31815a7ead.
Lee GA, Betz RR, Clements DH 3rd, Huss GK. Proximal kyphosis after posterior spinal fusion in patients with idiopathic scoliosis. Spine (Phila Pa 1976). 1999 Apr 15;24(8):795-9. doi: 10.1097/00007632-199904150-00011.
Yang SH, Chen PQ. Proximal kyphosis after short posterior fusion for thoracolumbar scoliosis. Clin Orthop Relat Res. 2003 Jun;(411):152-8. doi: 10.1097/01.blo.0000069885.72909.bb.
Kim YJ, Bridwell KH, Lenke LG, Glattes CR, Rhim S, Cheh G. Proximal junctional kyphosis in adult spinal deformity after segmental posterior spinal instrumentation and fusion: minimum five-year follow-up. Spine (Phila Pa 1976). 2008 Sep 15;33(20):2179-84. doi: 10.1097/BRS.0b013e31817c0428.
Helgeson MD, Shah SA, Newton PO, Clements DH 3rd, Betz RR, Marks MC, Bastrom T; Harms Study Group. Evaluation of proximal junctional kyphosis in adolescent idiopathic scoliosis following pedicle screw, hook, or hybrid instrumentation. Spine (Phila Pa 1976). 2010 Jan 15;35(2):177-81. doi: 10.1097/BRS.0b013e3181c77f8c.
Wang J, Zhao Y, Shen B, Wang C, Li M. Risk factor analysis of proximal junctional kyphosis after posterior fusion in patients with idiopathic scoliosis. Injury. 2010 Apr;41(4):415-20. doi: 10.1016/j.injury.2010.01.001. Epub 2010 Jan 27.
Bunge EM, Juttmann RE, de Kleuver M, van Biezen FC, de Koning HJ; NESCIO group. Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment. Eur Spine J. 2007 Jan;16(1):83-9. doi: 10.1007/s00586-006-0097-9. Epub 2006 Apr 12.
Taylor TC, Wenger DR, Stephen J, Gillespie R, Bobechko WP. Surgical management of thoracic kyphosis in adolescents. J Bone Joint Surg Am. 1979 Jun;61(4):496-503.
Glassman SD, Schwab F, Bridwell KH, Shaffrey C, Horton W, Hu S. Do 1-year outcomes predict 2-year outcomes for adult deformity surgery? Spine J. 2009 Apr;9(4):317-22. doi: 10.1016/j.spinee.2008.06.450. Epub 2008 Sep 6.
Other Identifiers
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RGC11-001
Identifier Type: -
Identifier Source: org_study_id
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