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

July 31, 2019 updated by: Globus Medical Inc

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Department of Orthopedic Surgery, University of Copenhagen, Denmark
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Peachtree Neurosurgery
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0338
        • Department of Neurosurgery, University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Less rigid rods
Titanium rods that have a soft, plastic end
Device: Less rigid rod
Titanium rod with semi rigid end
Other Names:
  • TRANSITION
Active Comparator: Rigid Rods
Titanium rods
Device: Rigid Rod
Rigid Titanium rods
Other Names:
  • REVERE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Globus Medical Inc

Collaborators

University of Michigan
Polaris Spine and Neurosurgery Center

Investigators

  • Study Director: Bryan Cunningham, PhD, Globus Medical Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Actual)

August 2, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGC11-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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