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 - Full Text View

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00890227

Purpose

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

Condition	Intervention
Scoliosis Kyphosis	Procedure: Traditional technique Procedure: Minimally invasive technique

MedlinePlus related topics: Scoliosis Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

To estimate the rate of proximal junctional fracture or instrumentation failure leading to kyphosis and loss of correction between two groups. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate complication rate between the two groups. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
To compare the total operative time, length of hospital stay, and total recovery time between the two groups of surgical patients (as stratified above). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To assess change in self-reported pain and functional limitations following surgery between two groups of surgical patients (as stratified above). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	68
Study Start Date:	June 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Traditional technique: Active Comparator All level open instrumented posterior spinal fusions	Procedure: Traditional technique All level open instrumented posterior spinal fusions
Minimally invasive technique: Active Comparator 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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890227

Contacts

Contact: Khaled M Kebaish, MD

443-287-2880

sorc@jhmi.edu

Locations

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

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

Khaled M Kebaish, MD

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins University ( Khaled M. Kebaish, MD )
Study ID Numbers:	SORC_KMK_08_006
Study First Received:	April 27, 2009
Last Updated:	April 27, 2009
ClinicalTrials.gov Identifier:	NCT00890227 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

scoliosis
kyphosis
Surgical treatment

Study placed in the following topic categories:

Spinal Diseases
Scoliosis
Musculoskeletal Diseases
Kyphosis
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Scoliosis
Spinal Curvatures

Musculoskeletal Diseases
Kyphosis
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009