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

Johns Hopkins University48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Scoliosis Kyphosis

Interventions

Traditional techniquePROCEDURE

All level open instrumented posterior spinal fusions

Minimally invasive techniquePROCEDURE

Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Johns Hopkins Outpatient Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

To evaluate complication rate between the two groups.

rate of complications

Time frame: 3 months

To compare the total operative time between the two groups of surgical patients (as stratified above).

operative time

Time frame: 12 months

To compare the length of hospital stay between the two groups of surgical patients (as stratified above).

length of hospital stay

Time frame: 12 months

To compare the total recovery time between the two groups of surgical patients (as stratified above).

total recovery time

Time frame: 12 months

To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).

pain rating

Time frame: 12 months

To assess change in self-reported functional limitations following surgery between two groups of surgical patients (as stratified above).

oswestry disability index

Time frame: 12 months

Data from ClinicalTrials.gov

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