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

This study is not yet open for participant recruitment.

Verified September 2011 by Globus Medical Inc

Sponsor:

Collaborators:

University of California, San Francisco

Carolina Neurosurgery & Spine Associates

University of Michigan

Peachtree Neurosurgery Atlanta, GA

Copenhagen University Hospital, Denmark

Scott and White Hospital & Clinic

Information provided by (Responsible Party):

Globus Medical Inc

ClinicalTrials.gov Identifier:

NCT01441999

First received: September 26, 2011

Last updated: September 29, 2011

Last verified: September 2011

History of Changes

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
Junctional Kyphosis	Device: Semi rigid rod Device: Rigid Rod	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 ] [ Designated as safety issue: No ]
Radiographs will be taken to measure lumbar lordosis, adjacent segment kyphosis, thoracolumbar kyphosis, saggital balance, Sacral slope and pelvic incidence.

Secondary Outcome Measures:

Patient outcome measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 2014
Estimated Primary Completion Date:	April 2014 (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: Semi 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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441999

Contacts

Contact: Sigurd Berven, MD	(415)514-1519	BervenS@orthosurg.ucsf.edu
Contact: Steven Takemoto, MD	(415) 476.6497	takemotoS@orthosurg.ucsf.edu

Locations

United States, Georgia
Peachtree Neurosurgery	Not yet 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	Not yet recruiting
Ann Arbor, Michigan, United States, 48109-0338
Contact: Frank LaMarca, MD 734-936-5024 flamarca@med.umich.edu
Principal Investigator: Frank LaMarca, MD
United States, North Carolina
Carolina Neurosurgery & Spine Associates	Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: Daniel Oberer, MD 704-831-3098 daniel.oberer@cnsa.com
Principal Investigator: Daniel Oberer, MD
United States, Texas
Scott & White Bone & Joint Institute	Not yet recruiting
Temple, Texas, United States, 76508
Contact: Mark D Rahm, MD 254-724-2663 ext 2 Mrahm@swmail.sw.org
Principal Investigator: Mark D Rahm, MD
Denmark
Department of Orthopedic Surgery, University of Copenhagen, Denmark	Not yet 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 California, San Francisco

Carolina Neurosurgery & Spine Associates

University of Michigan

Peachtree Neurosurgery Atlanta, GA

Copenhagen University Hospital, Denmark

Scott and White Hospital & Clinic

Investigators

Principal Investigator:

Sigurd Berven, MD

University of California, San Francisco

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.

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.

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.

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. 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. Epub 2008 Sep 6.

Responsible Party:	Globus Medical Inc
ClinicalTrials.gov Identifier:	NCT01441999 History of Changes
Other Study ID Numbers:	RGC11-001
Study First Received:	September 26, 2011
Last Updated:	September 29, 2011
Health Authority:	United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013

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