Clinical 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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Prospective Controlled Randomized Study Comparing Traditional Open Surgery to Minimally

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

Detailed Summary:

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.


Sponsor: Johns Hopkins University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: April 27, 2009
Date Started: June 2009
Date Completion: May 2011
Last Updated: April 27, 2009
Last Verified: April 2009