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

Not Applicable

Completed

• Conditions: Scoliosis; Kyphosis
• Interventions: Procedure: Traditional technique; Procedure: Minimally invasive technique

• Registration Number: NCT00890227
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-27
• Study First Posted: 2009-04-29
• Study Start: 2009-06
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional technique	Traditional technique	All level open instrumented posterior spinal fusions
Minimally invasive technique	Minimally invasive technique	Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.

Primary Outcome Measures

Name	Time	Method
To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups.	12 months	rate of proximal junctional fracture or instrumentation failure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Outpatient Center; 🇺🇸 Baltimore, Maryland, United States