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

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

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

Study Overview

• Status: Completed
• Conditions: Scoliosis; Kyphosis
• Intervention / Treatment: Procedure: Traditional technique; Procedure: Minimally invasive technique

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional technique; All level open instrumented posterior spinal fusions	Procedure: Traditional technique; All level open instrumented posterior spinal fusions
Active Comparator: Minimally invasive technique; Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.	Procedure: Minimally invasive technique; Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Khaled M Kebaish, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2009
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): April 29, 2009

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: scoliosis; kyphosis; Surgical treatment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Kyphosis
• Other Study ID Numbers: NA_00002729; SORC_KMK_08_006 (Other Identifier: JHU SOM Spine Outcomes Research Center)