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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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00890227
First received: April 27, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted

April 27, 2009
April 27, 2009
June 2009
May 2011   (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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • To evaluate complication rate between the two groups. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
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 Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Not yet recruiting
68
May 2011
May 2011   (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).
Both
18 Years and older
No
Contact: Khaled M Kebaish, MD 443-287-2880 sorc@jhmi.edu
United States
 
NCT00890227
SORC_KMK_08_006
No
Khaled M. Kebaish, MD, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Khaled M Kebaish, MD Johns Hopkins University
Johns Hopkins University
April 2009

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