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Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection (PJK)

This study is currently recruiting participants.
Verified August 2016 by Globus Medical Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT01441999
First Posted: September 28, 2011
Last Update Posted: August 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Michigan
Peachtree Neurosurgery PC Atlanta, GA
Information provided by (Responsible Party):
Globus Medical Inc
  Purpose

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.


Condition Intervention Phase
Kyphosis Device: Less rigid rod Device: Rigid Rod Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Proximal Junctional Kyphosis Following Long Instrumented Spinal Fusion: The Effect of Implant Selection

Further study details as provided by Globus Medical Inc:

Primary Outcome Measures:
  • Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits [ Time Frame: 2 years ]
    Radiographs will be taken to measure lumbar lordosis, adjacent segment kyphosis, thoracolumbar kyphosis, sagittal balance, Sacral slope and pelvic incidence.


Secondary Outcome Measures:
  • Patient outcome measures [ Time Frame: 2 years ]
    Forms to be completed at follow up visits will include VAS, SRS 22, SF12, ODI, Patient Satisfaction, Work Status Assessment and Odom's criteria.


Estimated Enrollment: 24
Study Start Date: October 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Less rigid rods
Titanium rods that have a soft, plastic end
Device: Less rigid rod
Titanium rod with semi rigid end
Other Name: TRANSITION
Active Comparator: Rigid Rods
Titanium rods
Device: Rigid Rod
Rigid Titanium rods
Other Name: REVERE

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441999


Contacts
Contact: Bryan Cunningham, PhD 610-930-1800 ext 2533

Locations
United States, Georgia
Peachtree Neurosurgery Recruiting
Atlanta, Georgia, United States, 30342
Contact: Thomas Morrison, MD    404-256-2633    maratom@bellsouth.net   
Principal Investigator: Thomas Morrison, MD         
United States, Michigan
Department of Neurosurgery, University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-0338
Contact: Frank LaMarca, MD    734-936-5024    flamarca@med.umich.edu   
Principal Investigator: Frank LaMarca, MD         
Denmark
Department of Orthopedic Surgery, University of Copenhagen, Denmark Recruiting
Copenhagen, Denmark, 2100
Contact: Benny Dahl, MD    45 40465555    bennydahl@gmail.com   
Principal Investigator: Benny Dahl, MD         
Sponsors and Collaborators
Globus Medical Inc
University of Michigan
Peachtree Neurosurgery PC Atlanta, GA
Investigators
Study Director: Bryan Cunningham, PhD Globus Medical Inc
  More Information

Publications:
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.
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.
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.
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.
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.
Yang SH, Chen PQ. Proximal kyphosis after short posterior fusion for thoracolumbar scoliosis. Clin Orthop Relat Res. 2003 Jun;(411):152-8.
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. 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.

Responsible Party: Globus Medical Inc
ClinicalTrials.gov Identifier: NCT01441999     History of Changes
Other Study ID Numbers: RGC11-001
First Submitted: September 26, 2011
First Posted: September 28, 2011
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by Globus Medical Inc:
Rigid rods
less rigid rods
prevent kyphosis
long constructs

Additional relevant MeSH terms:
Kyphosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases


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