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

NCT01441999 | Withdrawn

• 1 other identifier: RGC11-001
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

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.

Conditions

Kyphosis

Keywords

Rigid rods; less rigid rods; prevent kyphosis; long constructs

Outcome Measures

Primary Outcomes (1)

• Evidence of Proximal Junction Kyphosis as determined by radiographic measurements during follow up visits

  Radiographs will be taken to measure lumbar lordosis, adjacent segment kyphosis, thoracolumbar kyphosis, sagittal balance, Sacral slope and pelvic incidence.

  2 years

Secondary Outcomes (1)

• Patient outcome measures

  2 years

Study Arms (2)

Less rigid rods

ACTIVE COMPARATOR

Titanium rods that have a soft, plastic end

Device: Less rigid rod

Rigid Rods

ACTIVE COMPARATOR

Titanium rods

Device: Rigid Rod

Interventions

Less rigid rod DEVICE

Titanium rod with semi rigid end

Also known as: TRANSITION

Less rigid rods

Rigid Rod DEVICE

Rigid Titanium rods

Also known as: REVERE

Rigid Rods

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Globus Medical Inc: lead
• University of Michigan: collaborator
• Polaris Spine and Neurosurgery Center: collaborator

Study Sites (3)

Peachtree Neurosurgery

Atlanta, Georgia, 30342, United States

Location

Department of Neurosurgery, University of Michigan

Ann Arbor, Michigan, 48109-0338, United States

Location

Department of Orthopedic Surgery, University of Copenhagen, Denmark

Copenhagen, 2100, Denmark

Location

Related Publications (13)

• 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.

  PMID: 16025035 BACKGROUND

• 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.

  PMID: 17572624 BACKGROUND

• 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.

  PMID: 18580741 BACKGROUND

• 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.

  PMID: 16166893 BACKGROUND

• 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.

  PMID: 18007253 BACKGROUND

• 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.

  PMID: 10222531 BACKGROUND

• 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.

  PMID: 12782870 BACKGROUND

• 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.

  PMID: 18794759 BACKGROUND

• 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.

  PMID: 20081513 BACKGROUND

• 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.

  PMID: 20106476 BACKGROUND

• 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.

  PMID: 16609857 BACKGROUND

• 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.

  PMID: 438235 BACKGROUND

• 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.

  PMID: 18774752 BACKGROUND

MeSH Terms

Conditions

Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Bryan Cunningham, PhD

  Globus Medical Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2011
• First Posted: September 28, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 2, 2019

Record last verified: 2019-07

Locations

US (2); DK (1)