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
2 other identifiers
interventional
48
1 country
1
Brief Summary
This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedDecember 19, 2018
December 1, 2018
8.1 years
April 27, 2009
December 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
To evaluate complication rate between the two groups.
3 months
To compare the total operative time between the two groups of surgical patients (as stratified above).
12 months
To compare the length of hospital stay between the two groups of surgical patients (as stratified above).
12 months
To compare the total recovery time between the two groups of surgical patients (as stratified above).
12 months
To assess change in self-reported pain following surgery between two groups of surgical patients (as stratified above).
12 months
- +1 more secondary outcomes
Study Arms (2)
Traditional technique
ACTIVE COMPARATORAll level open instrumented posterior spinal fusions
Minimally invasive technique
ACTIVE COMPARATOROpen surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.
Interventions
All level open instrumented posterior spinal fusions
Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used.
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khaled M Kebaish, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2009
First Posted
April 29, 2009
Study Start
June 1, 2009
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
December 19, 2018
Record last verified: 2018-12