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

Scoliosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890227
• Other study ID #: NA_00002729
• Secondary ID: SORC_KMK_08_006
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: July 2017

Study information

• Verified date: December 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Kyphosis
• Scoliosis

Intervention

Procedure:
• Traditional technique
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.

Locations

Country	Name	City	State
United States	Johns Hopkins Outpatient Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	To evaluate complication rate between the two groups.	rate of complications	3 months
Secondary	To compare the total operative time between the two groups of surgical patients (as stratified above).	operative time	12 months
Secondary	To compare the length of hospital stay between the two groups of surgical patients (as stratified above).	length of hospital stay	12 months
Secondary	To compare the total recovery time between the two groups of surgical patients (as stratified above).	total recovery time	12 months
Secondary	To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).	pain rating	12 months
Secondary	To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).	oswestry disability index	12 months