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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Globus Medical Inc
Sponsor:
Collaborators:
University of California, San Francisco
University of Michigan
Peachtree Neurosurgery PC Atlanta, GA
Information provided by (Responsible Party):
Globus Medical Inc
ClinicalTrials.gov Identifier:
NCT01441999
First received: September 26, 2011
Last updated: August 29, 2013
Last verified: August 2013
  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
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, sagittal 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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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 California, San Francisco
University of Michigan
Peachtree Neurosurgery PC Atlanta, GA
Investigators
Principal Investigator: Sigurd Berven, MD University of California, San Francisco
  More Information

Publications:

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: August 29, 2013
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 September 18, 2014