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● Null hypothesis (H0): Unilateral pedicle screw with contralateral interbody cage has better outcomes than unilateral pedicle screw fixation with ipsilateral cage.
● Alternative hypothesis (H1):
Unilateral pedicle screw with contralateral interbody cage gives the same outcomes as unilateral pedicle screw fixation with ipsilateral cage.
Lumber interbody fusion is one of the commonest neurosurgical procedures. A lot of studies showed the value of unilateral approach which resulted in less cost, time and radiation exposure when use interbody cage with ipsilateral pedicular screws fixation in comparison to bilateral approach when use interbody cage with bilateral pedicular screws fixation.
Fusion rate, cage migration, and biomechanical stress were the main draw backs of unilateral approach by lumber interbody fusion with ipsilateral cage and screws. Cage size and location seemingly the main reasons with advice to use large cage and cage insertion in oblique fashion to cross the midline. This study was designed to solve these issues.
Sample size:
The Study will include 40 patients divided into two groups, each group containing 20 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | pedicle screw fixation on one side and intervertebral cage on the other sided |
|
| Group B | Active Comparator | pedicle screw fixation and interbody cage on the same side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pedicle screw fixation on one side and intervertebral cage on the other sided | Procedure | pedicle screw fixation on one side and intervertebral cage on the other sided |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of fusion status | Evaluation of fusion status using CT scan and Xray | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Back Pain | use of Visual Analogue Scale (VAS) as a 10-cm line labeled with (0= no pain and 10=worst pain) | At 24 hours, 2 weeks and 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wael Elmesallamy, M.D | Contact | 01142453993 | 002 | waelmesallamy50@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wael Elmesallamy, M.D | Zagazig University, Faculty of human medicine | Principal Investigator |
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| pedicle screw fixation and interbody cage on the same side | Procedure | pedicle screw fixation and interbody cage on the same side |
|