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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

Primary Purpose

Scoliosis, Kyphosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional technique
Minimally invasive technique
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Scoliosis focused on measuring scoliosis, kyphosis, Surgical treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Johns Hopkins Outpatient Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Traditional technique

Minimally invasive technique

Arm Description

All level open instrumented posterior spinal fusions

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

Outcomes

Primary Outcome Measures

To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.
rate of proximal junctional fracture or instrumentation failure

Secondary Outcome Measures

To evaluate complication rate between the two groups.
rate of complications
To compare the total operative time between the two groups of surgical patients (as stratified above).
operative time
To compare the length of hospital stay between the two groups of surgical patients (as stratified above).
length of hospital stay
To compare the total recovery time between the two groups of surgical patients (as stratified above).
total recovery time
To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).
pain rating
To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).
oswestry disability index

Full Information

First Posted
April 27, 2009
Last Updated
December 17, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT00890227
Brief Title
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
Official Title
Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Prospective Controlled Randomized Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion Levels/Levels
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Kyphosis
Keywords
scoliosis, kyphosis, Surgical treatment

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional technique
Arm Type
Active Comparator
Arm Description
All level open instrumented posterior spinal fusions
Arm Title
Minimally invasive technique
Arm Type
Active Comparator
Arm Description
Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.
Intervention Type
Procedure
Intervention Name(s)
Traditional technique
Intervention Description
All level open instrumented posterior spinal fusions
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive technique
Intervention Description
Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.
Primary Outcome Measure Information:
Title
To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.
Description
rate of proximal junctional fracture or instrumentation failure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
To evaluate complication rate between the two groups.
Description
rate of complications
Time Frame
3 months
Title
To compare the total operative time between the two groups of surgical patients (as stratified above).
Description
operative time
Time Frame
12 months
Title
To compare the length of hospital stay between the two groups of surgical patients (as stratified above).
Description
length of hospital stay
Time Frame
12 months
Title
To compare the total recovery time between the two groups of surgical patients (as stratified above).
Description
total recovery time
Time Frame
12 months
Title
To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).
Description
pain rating
Time Frame
12 months
Title
To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).
Description
oswestry disability index
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled M Kebaish, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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