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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Johns Hopkins University.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00890227
First received: April 27, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| 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 |
Resource links provided by NLM:
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 |
|---|---|
|
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.
|
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 | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Khaled M Kebaish, MD 443-287-2880 sorc@jhmi.edu | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Khaled M Kebaish, MD | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Khaled M. Kebaish, MD, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00890227 History of Changes |
| Other Study ID Numbers: | SORC_KMK_08_006 |
| Study First Received: | April 27, 2009 |
| Last Updated: | April 27, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
scoliosis kyphosis Surgical treatment |
Additional relevant MeSH terms:
|
Kyphosis Scoliosis Spinal Curvatures |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013