Clinical trial NCT00890227: 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
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Kyphosis
Keywords: scoliosis
kyphosis
Surgical treatment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-04-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate complication rate between the two groups.
timeFrame: 3 months
measure: To compare the total operative time between the two groups of surgical patients (as stratified above).
timeFrame: 12 months
measure: To compare the length of hospital stay between the two groups of surgical patients (as stratified above).
timeFrame: 12 months
measure: To compare the total recovery time between the two groups of surgical patients (as stratified above).
timeFrame: 12 months
measure: To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).
timeFrame: 12 months
measure: To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Khaled M Kebaish, MD
role: PRINCIPAL_INVESTIGATOR
References: