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| ID | Type | Description | Link |
|---|---|---|---|
| SORC_KMK_08_006 | Other Identifier | JHU SOM Spine Outcomes Research Center |
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This research is being done to compare two methods of surgery to treat scoliosis and/or kyphosis of the spine.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional technique | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional technique | Procedure | All level open instrumented posterior spinal fusions |
|
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khaled M Kebaish, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Outpatient Center | Baltimore | Maryland | 21287 | United States |
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| Minimally invasive technique | Procedure | Open surgery for all the levels except the proximal segment (most proximal instrumented level) where minimally invasive technique will be used. |
|
| 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 |
| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D007738 | Kyphosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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