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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

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ClinicalTrials.gov Identifier: NCT00890227
Recruitment Status : Active, not recruiting
First Posted : April 29, 2009
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

April 27, 2009
April 29, 2009
April 9, 2018
June 2009
October 2018   (Final data collection date for primary outcome measure)
To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups. [ Time Frame: 12 months ]
rate of proximal junctional fracture or instrumentation failure
To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups. [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00890227 on ClinicalTrials.gov Archive Site
  • To evaluate complication rate between the two groups. [ Time Frame: 3 months ]
    rate of complications
  • To compare the total operative time between the two groups of surgical patients (as stratified above). [ Time Frame: 12 months ]
    operative time
  • To compare the length of hospital stay between the two groups of surgical patients (as stratified above). [ Time Frame: 12 months ]
    length of hospital stay
  • To compare the total recovery time between the two groups of surgical patients (as stratified above). [ Time Frame: 12 months ]
    total recovery time
  • To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above). [ Time Frame: 12 months ]
    pain rating
  • To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above). [ Time Frame: 12 months ]
    oswestry disability index
  • To evaluate complication rate between the two groups. [ Time Frame: 3 months ]
  • To compare the total operative time, length of hospital stay, and total recovery time between the two groups of surgical patients (as stratified above). [ Time Frame: 12 months ]
  • To assess change in self-reported pain and functional limitations following surgery between two groups of surgical patients (as stratified above). [ Time Frame: 12 months ]
Not Provided
Not Provided
 
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
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
This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Scoliosis
  • Kyphosis
  • Procedure: Traditional technique
    All level open instrumented posterior spinal fusions
  • 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.
  • Active Comparator: Traditional technique
    All level open instrumented posterior spinal fusions
    Intervention: Procedure: Traditional technique
  • Active Comparator: 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: Procedure: Minimally invasive technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
68
Same as current
October 2018
October 2018   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00890227
NA_00002729
SORC_KMK_08_006 ( Other Identifier: JHU SOM Spine Outcomes Research Center )
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Khaled M Kebaish, MD Johns Hopkins University
Johns Hopkins University
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP