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

NCT01441999 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-08-02

No results posted yet for this study

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

Interventions

DEVICE

Less rigid rod

Titanium rod with semi rigid end

DEVICE

Rigid Rod

Rigid Titanium rods

Sponsors & Collaborators

  • University of Michigan

    collaborator OTHER

  • Polaris Spine and Neurosurgery Center

    collaborator OTHER

  • Globus Medical Inc

    lead INDUSTRY

Principal Investigators

  • Bryan Cunningham, PhD · Globus Medical Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • United States
  • Denmark

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01441999 on ClinicalTrials.gov