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Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion Levels

NCT ID: NCT00890227

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2017-07-31

Brief Summary

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This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.

Detailed Description

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Currently, there are two different surgical methods used in the treatment of these problems. One method includes an all open posterior spinal fusion (large incision with opening of the muscles); this is also known as a traditional technique. The second method involves an open surgery for the portion of the spine requiring a fusion except the very top area, where minimally invasive technique (smaller incision and without opening of the muscles) is used.

One possible side effect of either method for surgical repair is a condition called proximal junctional kyphosis (PJK). PJK occurs in the form of fracture at the top vertebra involved in the surgery or as a loss of correction of spinal alignment achieved, through gradual bending forward of the spine over time. In this study we want to compare the rate of PJK between two groups of patients undergoing long posterior spinal instrumentation fusion.

People undergoing long posterior spinal instrumented fusion may join.

About 68 people will join.

Conditions

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Scoliosis Kyphosis

Keywords

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scoliosis kyphosis Surgical treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Traditional technique

All level open instrumented posterior spinal fusions

Group Type ACTIVE_COMPARATOR

Traditional technique

Intervention Type PROCEDURE

All level open instrumented posterior spinal fusions

Minimally invasive technique

Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.

Group Type ACTIVE_COMPARATOR

Minimally invasive technique

Intervention Type PROCEDURE

Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.

Interventions

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Traditional technique

All level open instrumented posterior spinal fusions

Intervention Type PROCEDURE

Minimally invasive technique

Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Individuals presenting for surgical correction of scoliosis and/or kyphosis of the thoracolumbar spine are the primary target for enrollment.
* Men and women ages 18 years or older will be eligible for participation in the current study.
* In addition, individuals must be able to provide informed consent (Mini-Mental State Examination score of at least 18/30).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khaled M Kebaish, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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SORC_KMK_08_006

Identifier Type: OTHER

Identifier Source: secondary_id

NA_00002729

Identifier Type: -

Identifier Source: org_study_id